Back to resultsSafety Study of Zimura™in Combination With Anti-VEGF Therapy in Patients With Neovascular AMD
Primary Purpose
Macular Degeneration
Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Zimura
Avastin
Lucentis
Eylea
Sponsored by
About this trial
This is an interventional treatment trial for Macular Degeneration focused on measuring Neovascular age-related macular degeneration (NVAMD)
Eligibility Criteria
Inclusion Criteria:
- Treatment experienced subjects defined as subjects with 1 prior dose of same intravitreal anti-VEGF therapy given within the past 8 weeks for neovascular age-related macular degeneration (NVAMD) in the study eye. There must be < 0 letters of improvement in Snellen (not ETDRS Snellen equivalent) visual acuity since the start of anti-VEGF treatment.
- Presence of subfoveal active choroidal neovascularization (CNV)
Exclusion Criteria:
- Intravitreal treatment in the study eye prior to the Day 1 visit, regardless of indication, with the exception of the 1 prior anti-VEGF injections.
- Presence of other causes of choroidal neovascularization, including pathologic myopia, ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, and multifocal choroiditis.
- Non-pharmacologic treatment (intraocular surgery or thermal laser) within three months of trial entry.
- Prior thermal laser in the macular region, regardless of indication.
- Ocular or periocular infection in the past twelve weeks.
- History of any of the following conditions or procedures in the study eye: rhegmatogenous retinal detachment, pars plana vitrectomy, filtering surgery, glaucoma drainage device, or corneal transplant.
- Previous therapeutic radiation in the region of the study eye.
- Evidence of diabetic retinopathy
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Zimura and Avastin
Zimura and Lucentis
Zimura and Eylea
Arm Description
Participants receive three monthly Avastin treatments (Day 1, Month 1, and Month 2) followed by Zimura administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Avastin and Zimura.
Participants receive three monthly Lucentis treatments (Day 1, Month 1, and Month 2) followed by Zimura administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Lucentis and Zimura.
Participants receive three monthly Eylea treatments (Day 1, Month 1, and Month 2) followed by Zimura administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Eylea and Zimura.
Outcomes
Primary Outcome Measures
Percentage of Participants With >0 Letter Loss
Vision testing is performed using retroilluminated modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts at 4 meters.
Observed VA loss at Month 12 from Day 1 was assessed.
Percentage of Participants With >0 Letter Loss
Vision testing is performed using retroilluminated modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts at 4 meters.
Observed VA loss at Month 18 from Day 1 was assessed.
Percentage of Participants With >5 Letter Loss
Vision testing is performed using retroilluminated modified Ferris-Bailey ETDRS charts at 4 meters.
Observed VA loss at Month 12 from Day 1 was assessed.
Percentage of Participants With >5 Letter Loss
Vision testing is performed using retroilluminated modified Ferris-Bailey ETDRS charts at 4 meters.
Observed VA loss at Month 18 from Day 1 was assessed.
Percentage of Participants With >10 Letter Loss
Vision testing is performed using retroilluminated modified Ferris-Bailey ETDRS charts at 4 meters.
Observed VA loss at Month 12 from Day 1 was assessed.
Percentage of Participants With >10 Letter Loss
Vision testing is performed using retroilluminated modified Ferris-Bailey ETDRS charts at 4 meters.
Observed VA loss at Month 18 from Day 1 was assessed.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05571267
Brief Title
Safety Study of Zimura™in Combination With Anti-VEGF Therapy in Patients With Neovascular AMD
Official Title
A Phase 2A Randomized Open-Label Controlled Trial to Assess the Safety of Zimura™ (Anti-C5 Aptamer) Administered in Combination With Anti-VEGF Therapy in Treatment Experienced Patients With Neovascular Age-Related Macular Degeneration
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Terminated
Why Stopped
Following Sponsor reassessment, OPH2004 enrollment was stopped to initiate a new Zimura wet AMD trial, OPH2007, for treatment-naïve patients. Thus, only one patient was enrolled into and completed Study OPH2004.
Study Start Date
October 20, 2016 (Actual)
Primary Completion Date
April 24, 2018 (Actual)
Study Completion Date
April 24, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IVERIC bio, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary objective is to assess the safety of intravitreal (IVT) Zimura® administered in combination with anti-VEGF Therapy (AVASTIN®, EYLEA®, OR LUCENTIS®) in anti-VEGF treatment experienced subjects with neovascular age-related macular degeneration (AMD)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Degeneration
Keywords
Neovascular age-related macular degeneration (NVAMD)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Zimura and Avastin
Arm Type
Experimental
Arm Description
Participants receive three monthly Avastin treatments (Day 1, Month 1, and Month 2) followed by Zimura administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Avastin and Zimura.
Arm Title
Zimura and Lucentis
Arm Type
Experimental
Arm Description
Participants receive three monthly Lucentis treatments (Day 1, Month 1, and Month 2) followed by Zimura administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Lucentis and Zimura.
Arm Title
Zimura and Eylea
Arm Type
Experimental
Arm Description
Participants receive three monthly Eylea treatments (Day 1, Month 1, and Month 2) followed by Zimura administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Eylea and Zimura.
Intervention Type
Drug
Intervention Name(s)
Zimura
Other Intervention Name(s)
Avacincaptad Pegol, ARC1905
Intervention Description
Zimura 2 mg, administered by intravitreal injection
Intervention Type
Drug
Intervention Name(s)
Avastin
Other Intervention Name(s)
Bevacizumab
Intervention Description
Avastin 1.25 mg, administered by intravitreal injection
Intervention Type
Drug
Intervention Name(s)
Lucentis
Other Intervention Name(s)
Ranibizumab
Intervention Description
Lucentis 0.5 mg, administered by intravitreal injection
Intervention Type
Drug
Intervention Name(s)
Eylea
Other Intervention Name(s)
Aflibercept
Intervention Description
Eylea 2 mg, administered by intravitreal injection
Primary Outcome Measure Information:
Title
Percentage of Participants With >0 Letter Loss
Description
Vision testing is performed using retroilluminated modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts at 4 meters.
Observed VA loss at Month 12 from Day 1 was assessed.
Time Frame
Month 12
Title
Percentage of Participants With >0 Letter Loss
Description
Vision testing is performed using retroilluminated modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts at 4 meters.
Observed VA loss at Month 18 from Day 1 was assessed.
Time Frame
Month 18
Title
Percentage of Participants With >5 Letter Loss
Description
Vision testing is performed using retroilluminated modified Ferris-Bailey ETDRS charts at 4 meters.
Observed VA loss at Month 12 from Day 1 was assessed.
Time Frame
Month 12
Title
Percentage of Participants With >5 Letter Loss
Description
Vision testing is performed using retroilluminated modified Ferris-Bailey ETDRS charts at 4 meters.
Observed VA loss at Month 18 from Day 1 was assessed.
Time Frame
Month 18
Title
Percentage of Participants With >10 Letter Loss
Description
Vision testing is performed using retroilluminated modified Ferris-Bailey ETDRS charts at 4 meters.
Observed VA loss at Month 12 from Day 1 was assessed.
Time Frame
Month 12
Title
Percentage of Participants With >10 Letter Loss
Description
Vision testing is performed using retroilluminated modified Ferris-Bailey ETDRS charts at 4 meters.
Observed VA loss at Month 18 from Day 1 was assessed.
Time Frame
Month 18
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Treatment experienced subjects defined as subjects with 1 prior dose of same intravitreal anti-VEGF therapy given within the past 8 weeks for neovascular age-related macular degeneration (NVAMD) in the study eye. There must be < 0 letters of improvement in Snellen (not ETDRS Snellen equivalent) visual acuity since the start of anti-VEGF treatment.
Presence of subfoveal active choroidal neovascularization (CNV)
Exclusion Criteria:
Intravitreal treatment in the study eye prior to the Day 1 visit, regardless of indication, with the exception of the 1 prior anti-VEGF injections.
Presence of other causes of choroidal neovascularization, including pathologic myopia, ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, and multifocal choroiditis.
Non-pharmacologic treatment (intraocular surgery or thermal laser) within three months of trial entry.
Prior thermal laser in the macular region, regardless of indication.
Ocular or periocular infection in the past twelve weeks.
History of any of the following conditions or procedures in the study eye: rhegmatogenous retinal detachment, pars plana vitrectomy, filtering surgery, glaucoma drainage device, or corneal transplant.
Previous therapeutic radiation in the region of the study eye.
Evidence of diabetic retinopathy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
IVERIC bio, Inc.
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Safety Study of Zimura™in Combination With Anti-VEGF Therapy in Patients With Neovascular AMD
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