search
Back to results

A Study Of The Response to Treatment After Transition to The Port Delivery System With Ranibizumab [Susvimo (Ranibizumab Injection)] In Patients With Neovascular Age-Related Macular Degeneration Previously Treated With Intravitreal Agents Other Than Ranibizumab (Belvedere)

Primary Purpose

Neovascular Age-related Macular Degeneration

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
SUSVIMO (ranibizumab injection)
LUCENTIS (ranibizumab injection)
Sponsored by
Genentech, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neovascular Age-related Macular Degeneration

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

Ocular Inclusion Criteria

  • Initial diagnosis of nAMD within 6 to 18 months prior to screening
  • Previous treatment with at least 3 anti-VEGF injections other than ranibizumab for nAMD per standard of care within 9 months prior to Day 1 (SUSVIMO implantation); the most recent anti-VEGF injection must have occurred within 12 weeks of PDS implantation.
  • The last 2 anti-VEGF injections for nAMD prior to screening must be with either bevacizumab or aflibercept
  • Availability of historical visual acuity data and SD-OCT imaging prior to the first anti-VEGF IVT treatment for nAMD
  • Availability of comprehensive historical anti-VEGF injection data including anti-VEGF agent administered and date of administration from the first anti-VEGF treatment for nAMD
  • Demonstrated response to prior anti-VEGF intravitreal treatment since diagnosis BCVA of 34 letters (approximate 20/200 Snellen equivalent) or better, using ETDRS chart at a starting distance of 4 meters at screening and enrollment
  • All subtypes of nAMD lesions are permissible
  • nAMD lesions at the time of diagnosis must involve the macula (6 mm diameter centered at the fovea)
  • Sufficiently clear ocular media and adequate pupillary dilation to allow for clinical examination and analysis and grading by the central reading center of SD-OCT images

Substudy Inclusion Criteria

General Inclusion Criteria General inclusion criteria for this substudy are consistent with the inclusion criteria of the parent study ML43000. In addition, a signed Informed Consent for this substudy is required for participation.

Exclusion Criteria

Prior Ocular Treatment Study Eye

  • Prior vitrectomy surgery, submacular surgery, or other surgical intervention for AMD
  • Prior pars plana vitrectomy surgery
  • Prior treatment with ranibizumab
  • Prior treatment with verteporfin for injection, external-beam radiation therapy, or transpupillary thermotherapy
  • Previous treatment with corticosteroid intravitreal injection
  • Previous intraocular device implantation excluding intraocular lenses
  • Previous laser (any type) used for AMD treatment
  • History of vitreous hemorrhage
  • History of rhegmatogenous retinal detachment
  • History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery
  • History of corneal transplant
  • History of conjunctival surgery in the superotemporal quadrant
  • Prior participation in a clinical trial involving any intravitreal anti-VEGF agents

Fellow (Non-Study) Eye

• Previous PDS implantation

Either Eye

  • Previous intraocular surgery (including cataract surgery) within 6 months of study enrollment
  • Prior treatment with brolucizumab
  • Prior treatment with any anti-VEGF biosimilar agents
  • Prior treatment with external-beam radiation therapy or brachytherapy

MNV (CNV) Lesion Characteristics

Study Eye

  • Subretinal hemorrhage that involves the center of the fovea, if the hemorrhage is greater than 0.5-disc area (1.27 mm2) in size at screening
  • Subfoveal fibrosis or subfoveal atrophy

Either Eye

  • MNV due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia
  • MNV masquerading lesions (e.g., cone dystrophy, adult vitelliform dystrophy, pattern dystrophy)

Concurrent Ocular Conditions Study Eye

  • Retinal pigment epithelial tear
  • Any concurrent intraocular condition (e.g., cataract, glaucoma, diabetic retinopathy, or epiretinal membrane) that would either require surgical intervention during the study to prevent or treat visual loss that might result from that condition or affect interpretation of study results
  • Retinal tears or peripheral retinal breaks on depressed fundus exam that are untreated, or treated within the 3 months prior to study enrollment
  • Aphakia or absence of the posterior capsule
  • Previous violation of the posterior capsule is also an exclusion criterion unless it occurred as a result of yttrium-aluminum garnet (YAG) laser posterior capsulotomy in association with prior, posterior chamber intraocular lens implantation
  • Spherical equivalent of the refractive error demonstrating more than 8 diopters of myopia or evidence of pathologic myopia on depressed fundus exam
  • Preoperative refractive error that exceeds 8 diopters of myopia, for patients who have undergone prior refractive or cataract surgery
  • Spherical equivalent of the refractive error demonstrating more than 5 diopters of hyperopia
  • Preoperative refractive error that exceeds 5 diopters of hyperopia, for patients who have undergone prior refractive or cataract surgery
  • Uncontrolled ocular hypertension or glaucoma
  • Scleral pathology in the superotemporal quadrant (e.g., scleral thinning or calcification)
  • Conjunctival pathologies in the superotemporal quadrant
  • History or presence of severe posterior blepharitis, recurrent chalazia or hordeolum, severe dry eye syndrome, or severe allergic conjunctivitis
  • Ectropion, entropion or other impairment of the upper or lower eyelid impacting lid functionality needed to protect the ocular surface from exposure
  • Trichiasis
  • Corneal neuropathy
  • Lagophthalmos or incomplete blink
  • Active or history of facial nerve palsy/paresis

Fellow (Non-Study) Eye

  • Concurrent intraocular condition that would require surgical intervention during the study (e.g., cataract, glaucoma surgery)
  • Concurrent PDS implantation

Either Eye

  • Any active or history of uveitis (e.g., idiopathic, drug-associated or autoimmuneassociated)
  • Active or history of keratitis, scleritis, or endophthalmitis
  • Active ocular or periocular infection (i.e. conjunctivitis, dacryocystitis etc.)
  • Active or history of Sjogrens syndrome or keratoconjunctivitis sicca
  • Active or history of floppy eyelid syndrome
  • Active or history of chronic eye rubbing
  • Active thyroid eye disease

Concurrent Systemic Conditions

  • Uncontrolled blood pressure
  • Active or history of autoimmune diseases such as rheumatoid arthritis, lupus, granulomatosis with polyangiitis (Wegner's), etc.
  • History of stroke within the last 3 months prior to screening
  • Uncontrolled atrial fibrillation within 3 months of screening
  • History of myocardial infarction within the last 3 months prior to screening
  • History of other disease, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of ranibizumab or placement of the implant and that might affect interpretation of the results of the study or renders the patient at high risk of treatment complications, in the opinion of the investigator
  • Current active systemic infection
  • Use of any systemic anti-VEGF agents
  • Chronic use of oral corticosteroids
  • Active cancer within 12 months of enrollment except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, and prostate cancer with a Gleason score of ≤ 6 and a stable prostate-specific antigen for > 12 months
  • Previous participation in any non-ocular (systemic) disease studies of investigational drugs within 1 month prior to screening (excluding vitamins and minerals)
  • Use of antimitotic or antimetabolite therapy within 30 days or 5 elimination half-lives of the screening visit
  • Pregnant or breastfeeding, or intention to become pregnant during the study
  • Women of childbearing potential, must have a negative urine pregnancy test result within 28 days prior to initiation of study treatment. If the urine pregnancy test is positive, it must be confirmed by a serum pregnancy test.

Substudy Exclusion Criteria

Exclusion criteria for this substudy are consistent with the exclusion criteria of the parent Study ML43000

Fellow (Non-Study) Eye

  • Prior vitrectomy surgery, submacular surgery, or other surgical intervention for AMD
  • Prior pars plana vitrectomy surgery
  • Previous intraocular device implantation excluding intraocular lenses
  • History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery
  • Prior participation in a clinical trial involving any intravitreal anti-VEGF agents

Either Eye

  • Intraocular laser therapy including selective laser trabeculoplasty, yttrium-aluminum garnet (YAG), prophylactic peripheral iridotomy within 1 year of screening, or YAG capsulotomy within 3 months of screening
  • Contact lens wear in either eye within 2 months of screening
  • Any prior ocular trauma (blunt or penetrating)
  • History of corneal transplantation, including partial-thickness corneal grafts (e.g., Descemet membrane endothelial keratoplasty, Descemet stripping endothelial keratoplasty)

Concurrent Ocular Conditions

Fellow Eye

• Aphakia or absence of the posterior pole

Either Eye

  • Corneal ECD < 1500 cells/mm2 in either eye at screening as determined by the independent reading center
  • Fuchs endothelial corneal dystrophy Grade ≥ 2
  • Previous corneal endothelial cell damage, including from blunt or surgical trauma (including complicated cataract surgery resulting in complicated lens placement such as anterior chamber intraocular lens, sulcus intraocular lens, aphakia, etc.)
  • Any ocular condition that precludes obtaining an analyzable specular microscopy image
  • Active or history of corneal edema
  • Active or history of corneal dystrophies
  • Active or history of iridocorneal endothelial syndrome
  • Active or history of pseudoexfoliation syndrome
  • Active or history of herpetic keratitis or kerato-uveitis (including herpes simplex virus and herpes zoster virus)

Sites / Locations

  • Barnet Dulaney Perkins Eye CenterRecruiting
  • California Retina ConsultantsRecruiting
  • California Eye Specialists Medical group Inc.Recruiting
  • Retinal Consultants Med GroupRecruiting
  • Orange County Retina Med GroupRecruiting
  • Southwest Retina ConsultantsRecruiting
  • Retina Group of New England
  • Ft Lauderdale Eye Institute
  • Retina Specialty InstituteRecruiting
  • Retina Vitreous Associates of FloridaRecruiting
  • Southeast Retina CenterRecruiting
  • University Retina and Macula Associates, PCRecruiting
  • Wolfe Eye ClinicRecruiting
  • Retina Associates of KentuckyRecruiting
  • The Retina Care CenterRecruiting
  • Wilmer Eye Institute Johns Hopkins UniversityRecruiting
  • Retina Group of Washington
  • Cumberland Valley Retina ConsultantsRecruiting
  • Associated Retinal Consultants PCRecruiting
  • VitreoRetinal Surgery, PLLC.; DBA Retina Consultants of MinnesotaRecruiting
  • Midwest Vision Research FoundationRecruiting
  • Sierra Eye AssociatesRecruiting
  • Mid Atlantic Retina
  • Western Carolina Retinal Associate PA
  • Cincinnati Eye InstituteRecruiting
  • Palmetto Retina Center, LLC
  • Palmetto Retina CenterRecruiting
  • Tennessee Retina PCRecruiting
  • Austin Retina AssociatesRecruiting
  • Retina Consultants of TexasRecruiting
  • Retina Associates of Utah, PLLCRecruiting
  • Piedmont Eye CenterRecruiting
  • Wagner Kapoor InstituteRecruiting
  • Retina Institute of VirginiaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SUSVIMO

Arm Description

Participants will have the implant (filled prior to implantation with approximately 20 uL of the 100-mg/mL formulation of ranibizumab [approximately 2-mg dose of ranibizumab]) surgically inserted in the study eye at the Day 1 visit following their enrollment visit. After the initial fill of the implant with ranibizumab, patients will receive implant refill-exchanges at fixed 24-week intervals.

Outcomes

Primary Outcome Measures

Mean change from baseline in Best Corrected Visual Acuity (BCVA) letter score at Week 40, as assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart at a starting distance of 4 meters
PDS 100 mg/mL Q24W in nAMD particpants previously treated with intravitreal anti-VEGF agents other than ranibizumab
Substudy: Change in corneal endothelial cell density (ECD) from baseline at Week 48 in the study eye as compared with the fellow eye, as assessed by specular microscopy

Secondary Outcome Measures

Mean change from baseline in BCVA letter score at Week 40, as assessed using the ETDRS visual acuity chart at a starting distance of 4 meters
PDS 100 mg/mL Q24W in participants with nAMD by subgroup as defined by the last two consecutive anti-VEGF agent administered to the study eye prior to Day 1, aflibercept or bevacizumab
Percentage of participants with BCVA score of 69 letters (approximate 20/40 Snellen equivalent) or better at each scheduled visit over time to Week 52
Percentage of participants who lose < 15, < 10, < 5, or gain ≥ 0, > 0, ≥ 5, ≥ 10, or ≥15 letters in BCVA score from enrollment at each scheduled visit over time to Week 52
Annualized rate of ranibizumab treatments during the study compared with annualized rate of intravitreal anti-VEGF treatments prior to screening
Mean change in center point thickness (CPT) from baseline on spectral-domain optical coherence tomography (SD-OCT) at each scheduled visit over time to Week 52
Percentage of participants who do not require supplemental treatment with intravitreal LUCENTIS (ranibizumab injection) 0.5 mg prior to protocol-specified refill-exchanges
Percentage of participants with and without subretinal (SRF) and/or intraretinal fluid (IRF) on SD-OCT at enrollment and over study duration
Percentage of participants with ocular serious adverse events (SAEs)
Percentage of participants with ocular adverse events of special interest (AESIs)
Percentage of participants with adverse device effects (ADEs) in the course of the study
Percentage of participants with ocular AESIs during the postoperative period
Percentage of participants with ocular AESIs during the intermediate postoperative period
Percentage of participants with ocular AESIs during the follow-up period
The investigator will follow each adverse event until the event has resolved to baseline grade or better, the event is assessed as stable by the investigator, the patient is lost to follow-up, or the patient withdraws consent.
Change in corneal ECD from baseline at Week 24 in the study eye as compared with the fellow eye
Change in the coefficient of variation (CV) of corneal endothelial cell area (standard deviation of the cell area/mean cell area) from baseline at Weeks 24 and 48 in the study eye as compared with the fellow eye
Change in percentage of hexagonal endothelial cells

Full Information

First Posted
April 16, 2021
Last Updated
October 3, 2023
Sponsor
Genentech, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT04853251
Brief Title
A Study Of The Response to Treatment After Transition to The Port Delivery System With Ranibizumab [Susvimo (Ranibizumab Injection)] In Patients With Neovascular Age-Related Macular Degeneration Previously Treated With Intravitreal Agents Other Than Ranibizumab
Acronym
Belvedere
Official Title
A Phase IV, Multicenter, Open-Label, Single-Arm Study Of The Response to Treatment After Transition to The Port Delivery System With Ranibizumab [Susvimo (Ranibizumab Injection)] In Patients With Neovascular Age-Related Macular Degeneration Previously Treated With Intravitreal Agents Other Than Ranibizumab
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 14, 2021 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
Study ML43000 is a Phase IV multicenter, open-label (BCVA assessor-masked) study designed to assess the response to treatment with SUSVIMO Q24W in patients with nAMD who have been previously treated with anti-VEGF agents other than ranibizumab. The substudy will evaluate the impact on corneal endothelial cells with SUSVIMO refilled every 24 weeks (Q24W) in patients with neovascular age-related macular degeneration (nAMD).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neovascular Age-related Macular Degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SUSVIMO
Arm Type
Experimental
Arm Description
Participants will have the implant (filled prior to implantation with approximately 20 uL of the 100-mg/mL formulation of ranibizumab [approximately 2-mg dose of ranibizumab]) surgically inserted in the study eye at the Day 1 visit following their enrollment visit. After the initial fill of the implant with ranibizumab, patients will receive implant refill-exchanges at fixed 24-week intervals.
Intervention Type
Device
Intervention Name(s)
SUSVIMO (ranibizumab injection)
Intervention Description
The ranibizumab 100 mg/mL will be administered to participants via the SUSVIMO Ocular Implant (IMP)
Intervention Type
Drug
Intervention Name(s)
LUCENTIS (ranibizumab injection)
Intervention Description
Ranibizumab (intravitreal 0.5-mg injections of 10 mg/mL formulation) will be used in the study eye as supplemental treatment. If a study patient discontinues study treatment, he/she may start receiving intravitreal ranibizumab injections in the study eye, per investigator's discretion.
Primary Outcome Measure Information:
Title
Mean change from baseline in Best Corrected Visual Acuity (BCVA) letter score at Week 40, as assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart at a starting distance of 4 meters
Description
PDS 100 mg/mL Q24W in nAMD particpants previously treated with intravitreal anti-VEGF agents other than ranibizumab
Time Frame
Baseline up to Week 40
Title
Substudy: Change in corneal endothelial cell density (ECD) from baseline at Week 48 in the study eye as compared with the fellow eye, as assessed by specular microscopy
Time Frame
Baseline up to Week 48
Secondary Outcome Measure Information:
Title
Mean change from baseline in BCVA letter score at Week 40, as assessed using the ETDRS visual acuity chart at a starting distance of 4 meters
Description
PDS 100 mg/mL Q24W in participants with nAMD by subgroup as defined by the last two consecutive anti-VEGF agent administered to the study eye prior to Day 1, aflibercept or bevacizumab
Time Frame
Baseline up to Week 40
Title
Percentage of participants with BCVA score of 69 letters (approximate 20/40 Snellen equivalent) or better at each scheduled visit over time to Week 52
Time Frame
Baseline up to Week 52
Title
Percentage of participants who lose < 15, < 10, < 5, or gain ≥ 0, > 0, ≥ 5, ≥ 10, or ≥15 letters in BCVA score from enrollment at each scheduled visit over time to Week 52
Time Frame
Baseline up to Week 52
Title
Annualized rate of ranibizumab treatments during the study compared with annualized rate of intravitreal anti-VEGF treatments prior to screening
Time Frame
Baseline up to approximately 12 months
Title
Mean change in center point thickness (CPT) from baseline on spectral-domain optical coherence tomography (SD-OCT) at each scheduled visit over time to Week 52
Time Frame
Baseline up to Week 52
Title
Percentage of participants who do not require supplemental treatment with intravitreal LUCENTIS (ranibizumab injection) 0.5 mg prior to protocol-specified refill-exchanges
Time Frame
Day 1 to Week 48
Title
Percentage of participants with and without subretinal (SRF) and/or intraretinal fluid (IRF) on SD-OCT at enrollment and over study duration
Time Frame
Baseline up to approximately Week 52
Title
Percentage of participants with ocular serious adverse events (SAEs)
Time Frame
Day 1 up to approximately Week 52
Title
Percentage of participants with ocular adverse events of special interest (AESIs)
Time Frame
Day 1 to Week 52
Title
Percentage of participants with adverse device effects (ADEs) in the course of the study
Time Frame
Day 1 to Week 52
Title
Percentage of participants with ocular AESIs during the postoperative period
Time Frame
Baseline up to 37 days of initial implantation
Title
Percentage of participants with ocular AESIs during the intermediate postoperative period
Time Frame
38 to 93 days after implantation
Title
Percentage of participants with ocular AESIs during the follow-up period
Description
The investigator will follow each adverse event until the event has resolved to baseline grade or better, the event is assessed as stable by the investigator, the patient is lost to follow-up, or the patient withdraws consent.
Time Frame
Week 52
Title
Change in corneal ECD from baseline at Week 24 in the study eye as compared with the fellow eye
Time Frame
Baseline up to Week 24
Title
Change in the coefficient of variation (CV) of corneal endothelial cell area (standard deviation of the cell area/mean cell area) from baseline at Weeks 24 and 48 in the study eye as compared with the fellow eye
Time Frame
Baseline, Week 24, Week 48
Title
Change in percentage of hexagonal endothelial cells
Time Frame
Baseline, Week 24, Week 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Ocular Inclusion Criteria Initial diagnosis of nAMD within 6 to 18 months prior to screening Previous treatment with at least 3 anti-VEGF injections other than ranibizumab for nAMD per standard of care within 9 months prior to Day 1 (SUSVIMO implantation); the most recent anti-VEGF injection must have occurred within 12 weeks of PDS implantation. The last 2 anti-VEGF injections for nAMD prior to screening must be with either bevacizumab or aflibercept Availability of historical visual acuity data and SD-OCT imaging prior to the first anti-VEGF IVT treatment for nAMD Availability of comprehensive historical anti-VEGF injection data including anti-VEGF agent administered and date of administration from the first anti-VEGF treatment for nAMD Demonstrated response to prior anti-VEGF intravitreal treatment since diagnosis BCVA of 34 letters (approximate 20/200 Snellen equivalent) or better, using ETDRS chart at a starting distance of 4 meters at screening and enrollment All subtypes of nAMD lesions are permissible nAMD lesions at the time of diagnosis must involve the macula (6 mm diameter centered at the fovea) Sufficiently clear ocular media and adequate pupillary dilation to allow for clinical examination and analysis and grading by the central reading center of SD-OCT images Substudy Inclusion Criteria General Inclusion Criteria General inclusion criteria for this substudy are consistent with the inclusion criteria of the parent study ML43000. In addition, a signed Informed Consent for this substudy is required for participation. Exclusion Criteria Prior Ocular Treatment Study Eye Prior vitrectomy surgery, submacular surgery, or other surgical intervention for AMD Prior pars plana vitrectomy surgery Prior treatment with ranibizumab Prior treatment with verteporfin for injection, external-beam radiation therapy, or transpupillary thermotherapy Previous treatment with corticosteroid intravitreal injection Previous intraocular device implantation excluding intraocular lenses Previous laser (any type) used for AMD treatment History of vitreous hemorrhage History of rhegmatogenous retinal detachment History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery History of corneal transplant History of conjunctival surgery in the superotemporal quadrant Prior participation in a clinical trial involving any intravitreal anti-VEGF agents Fellow (Non-Study) Eye • Previous PDS implantation Either Eye Previous intraocular surgery (including cataract surgery) within 6 months of study enrollment Prior treatment with brolucizumab Prior treatment with any anti-VEGF biosimilar agents Prior treatment with external-beam radiation therapy or brachytherapy MNV (CNV) Lesion Characteristics Study Eye Subretinal hemorrhage that involves the center of the fovea, if the hemorrhage is greater than 0.5-disc area (1.27 mm2) in size at screening Subfoveal fibrosis or subfoveal atrophy Either Eye MNV due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia MNV masquerading lesions (e.g., cone dystrophy, adult vitelliform dystrophy, pattern dystrophy) Concurrent Ocular Conditions Study Eye Retinal pigment epithelial tear Any concurrent intraocular condition (e.g., cataract, glaucoma, diabetic retinopathy, or epiretinal membrane) that would either require surgical intervention during the study to prevent or treat visual loss that might result from that condition or affect interpretation of study results Retinal tears or peripheral retinal breaks on depressed fundus exam that are untreated, or treated within the 3 months prior to study enrollment Aphakia or absence of the posterior capsule Previous violation of the posterior capsule is also an exclusion criterion unless it occurred as a result of yttrium-aluminum garnet (YAG) laser posterior capsulotomy in association with prior, posterior chamber intraocular lens implantation Spherical equivalent of the refractive error demonstrating more than 8 diopters of myopia or evidence of pathologic myopia on depressed fundus exam Preoperative refractive error that exceeds 8 diopters of myopia, for patients who have undergone prior refractive or cataract surgery Spherical equivalent of the refractive error demonstrating more than 5 diopters of hyperopia Preoperative refractive error that exceeds 5 diopters of hyperopia, for patients who have undergone prior refractive or cataract surgery Uncontrolled ocular hypertension or glaucoma Scleral pathology in the superotemporal quadrant (e.g., scleral thinning or calcification) Conjunctival pathologies in the superotemporal quadrant History or presence of severe posterior blepharitis, recurrent chalazia or hordeolum, severe dry eye syndrome, or severe allergic conjunctivitis Ectropion, entropion or other impairment of the upper or lower eyelid impacting lid functionality needed to protect the ocular surface from exposure Trichiasis Corneal neuropathy Lagophthalmos or incomplete blink Active or history of facial nerve palsy/paresis Fellow (Non-Study) Eye Concurrent intraocular condition that would require surgical intervention during the study (e.g., cataract, glaucoma surgery) Concurrent PDS implantation Either Eye Any active or history of uveitis (e.g., idiopathic, drug-associated or autoimmuneassociated) Active or history of keratitis, scleritis, or endophthalmitis Active ocular or periocular infection (i.e. conjunctivitis, dacryocystitis etc.) Active or history of Sjogrens syndrome or keratoconjunctivitis sicca Active or history of floppy eyelid syndrome Active or history of chronic eye rubbing Active thyroid eye disease Concurrent Systemic Conditions Uncontrolled blood pressure Active or history of autoimmune diseases such as rheumatoid arthritis, lupus, granulomatosis with polyangiitis (Wegner's), etc. History of stroke within the last 3 months prior to screening Uncontrolled atrial fibrillation within 3 months of screening History of myocardial infarction within the last 3 months prior to screening History of other disease, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of ranibizumab or placement of the implant and that might affect interpretation of the results of the study or renders the patient at high risk of treatment complications, in the opinion of the investigator Current active systemic infection Use of any systemic anti-VEGF agents Chronic use of oral corticosteroids Active cancer within 12 months of enrollment except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, and prostate cancer with a Gleason score of ≤ 6 and a stable prostate-specific antigen for > 12 months Previous participation in any non-ocular (systemic) disease studies of investigational drugs within 1 month prior to screening (excluding vitamins and minerals) Use of antimitotic or antimetabolite therapy within 30 days or 5 elimination half-lives of the screening visit Pregnant or breastfeeding, or intention to become pregnant during the study Women of childbearing potential, must have a negative urine pregnancy test result within 28 days prior to initiation of study treatment. If the urine pregnancy test is positive, it must be confirmed by a serum pregnancy test. Substudy Exclusion Criteria Exclusion criteria for this substudy are consistent with the exclusion criteria of the parent Study ML43000 Fellow (Non-Study) Eye Prior vitrectomy surgery, submacular surgery, or other surgical intervention for AMD Prior pars plana vitrectomy surgery Previous intraocular device implantation excluding intraocular lenses History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery Prior participation in a clinical trial involving any intravitreal anti-VEGF agents Either Eye Intraocular laser therapy including selective laser trabeculoplasty, yttrium-aluminum garnet (YAG), prophylactic peripheral iridotomy within 1 year of screening, or YAG capsulotomy within 3 months of screening Contact lens wear in either eye within 2 months of screening Any prior ocular trauma (blunt or penetrating) History of corneal transplantation, including partial-thickness corneal grafts (e.g., Descemet membrane endothelial keratoplasty, Descemet stripping endothelial keratoplasty) Concurrent Ocular Conditions Fellow Eye • Aphakia or absence of the posterior pole Either Eye Corneal ECD < 1500 cells/mm2 in either eye at screening as determined by the independent reading center Fuchs endothelial corneal dystrophy Grade ≥ 2 Previous corneal endothelial cell damage, including from blunt or surgical trauma (including complicated cataract surgery resulting in complicated lens placement such as anterior chamber intraocular lens, sulcus intraocular lens, aphakia, etc.) Any ocular condition that precludes obtaining an analyzable specular microscopy image Active or history of corneal edema Active or history of corneal dystrophies Active or history of iridocorneal endothelial syndrome Active or history of pseudoexfoliation syndrome Active or history of herpetic keratitis or kerato-uveitis (including herpes simplex virus and herpes zoster virus)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reference Study ID Number: ML43000 https://forpatients.roche.com/
Phone
888-662-6728 (U.S.)
Email
global-roche-genentech-trials@gene.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Genetech
Official's Role
Study Director
Facility Information:
Facility Name
Barnet Dulaney Perkins Eye Center
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85206
Country
United States
Individual Site Status
Recruiting
Facility Name
California Retina Consultants
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Individual Site Status
Recruiting
Facility Name
California Eye Specialists Medical group Inc.
City
Pasadena
State/Province
California
ZIP/Postal Code
91107
Country
United States
Individual Site Status
Recruiting
Facility Name
Retinal Consultants Med Group
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Individual Site Status
Recruiting
Facility Name
Orange County Retina Med Group
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Individual Site Status
Recruiting
Facility Name
Southwest Retina Consultants
City
Durango
State/Province
Colorado
ZIP/Postal Code
81303
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Group of New England
City
Waterford
State/Province
Connecticut
ZIP/Postal Code
06385
Country
United States
Individual Site Status
Withdrawn
Facility Name
Ft Lauderdale Eye Institute
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Individual Site Status
Withdrawn
Facility Name
Retina Specialty Institute
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Vitreous Associates of Florida
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33711-1141
Country
United States
Individual Site Status
Recruiting
Facility Name
Southeast Retina Center
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Individual Site Status
Recruiting
Facility Name
University Retina and Macula Associates, PC
City
Oak Forest
State/Province
Illinois
ZIP/Postal Code
60452
Country
United States
Individual Site Status
Recruiting
Facility Name
Wolfe Eye Clinic
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Associates of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Individual Site Status
Recruiting
Facility Name
The Retina Care Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21209
Country
United States
Individual Site Status
Recruiting
Facility Name
Wilmer Eye Institute Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287-0005
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Group of Washington
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Individual Site Status
Withdrawn
Facility Name
Cumberland Valley Retina Consultants
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740-5940
Country
United States
Individual Site Status
Recruiting
Facility Name
Associated Retinal Consultants PC
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Individual Site Status
Recruiting
Facility Name
VitreoRetinal Surgery, PLLC.; DBA Retina Consultants of Minnesota
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Individual Site Status
Recruiting
Facility Name
Midwest Vision Research Foundation
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Individual Site Status
Recruiting
Facility Name
Sierra Eye Associates
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Individual Site Status
Recruiting
Facility Name
Mid Atlantic Retina
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08034
Country
United States
Individual Site Status
Withdrawn
Facility Name
Western Carolina Retinal Associate PA
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Individual Site Status
Withdrawn
Facility Name
Cincinnati Eye Institute
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Individual Site Status
Recruiting
Facility Name
Palmetto Retina Center, LLC
City
West Columbia
State/Province
South Carolina
ZIP/Postal Code
29169
Country
United States
Individual Site Status
Withdrawn
Facility Name
Palmetto Retina Center
City
West Columbia
State/Province
South Carolina
ZIP/Postal Code
29169
Country
United States
Individual Site Status
Recruiting
Facility Name
Tennessee Retina PC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Name
Austin Retina Associates
City
Austin
State/Province
Texas
ZIP/Postal Code
78705-1169
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Consultants of Texas
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77384-4167
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Associates of Utah, PLLC
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Individual Site Status
Recruiting
Facility Name
Piedmont Eye Center
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24502
Country
United States
Individual Site Status
Recruiting
Facility Name
Wagner Kapoor Institute
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Institute of Virginia
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23235
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

A Study Of The Response to Treatment After Transition to The Port Delivery System With Ranibizumab [Susvimo (Ranibizumab Injection)] In Patients With Neovascular Age-Related Macular Degeneration Previously Treated With Intravitreal Agents Other Than Ranibizumab

We'll reach out to this number within 24 hrs