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Efficacy of Biweekly Ranibizumab (0.5 mg) for Exudative Macular Degeneration Retinal Edema Refractory to Anti-VEGF

Primary Purpose

Exudative Age Related Macular Degeneration

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Ranibizumab Injection [Lucentis]

About this trial

This is an interventional treatment trial for Exudative Age Related Macular Degeneration focused on measuring Macular Degeneration, AMD, Wet AMD, Lucentis

Eligibility Criteria

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

Inclusion Criteria:

Age > 50 years
Exudative age related macular degeneration in study eye involving the fovea
Best Corrected Visual Acuity (by ETDRS) letter score in study eye of < 85 and > 24 (approximate Snellen equivalent 20/20 to 20/320)
Persistent intraretinal or subretinal fluid on SD OCT despite a minimum of 5 intravitreal anti-VEGF injections administered every 4-6 weeks in the in the 6 months preceding enrollment in the study eye
At least 30 days from last intravitreal anti-VEGF injection in the study eye

Exclusion Criteria:

Patient who are receiving systemic anti-VEGF or proangiogenic therapy
Patients on chronic high doses corticosteroid therapy (> than 10 mg of oral prednisone or equivalent greater than 10 days)
Patients on chronic immunosuppressant therapy
Patients on drugs known to have toxic side effects on the retina e.g. hydroxychloroquine
History of intravitreal corticosteroids in study eye within 4 months of baseline
Uncontrolled hypertension (defined as systolic >180 mm Hg and/or diastolic > 100 mm Hg while patient is sitting)
History of stroke or APTC event in the previous year
Any intraocular surgery in study eye within 90 days of baseline
Presence of vitreomacular traction in study eye
Presence of significant epiretinal proliferation in study eye
Evidence of active infection in either eye
Uncontrolled glaucoma in the study eye defined as a pressure > 25 mmHg on maximal medical therapy

Sites / Locations

Charlotte Eye Ear Nose and Throat Associates, PA
Charlotte Eye Ear Nose and Throat Associates, PA

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

ranibizumab

ranibizumab pre filled-syringe

Arm Description

ranibizumab 0.5mg in commercially available vial

ranibizumab 0.5mg in soon to be available pre-filled syringe

Outcomes

Primary Outcome Measures

The primary outcome measure is mean change in ETDRS BCVA visual acuity

The primary outcome measure is mean change in ETDRS BCVA visual acuity at 24 weeks compared to baseline.

Secondary Outcome Measures

Proportion of eyes that gain or lose >0 letters at 24 weeks

Proportion of eyes that gain or lose > 5 letters at 24 weeks

Proportion of eyes that gain or lose > 10 letters at 24 weeks

Proportion of eyes that gain or lose > 15 letters at 24 weeks

To compare syringe preparation time (SPT) using ranibizumab vial and pre-filled syringe (PFS) in a real world clinical setting

• Proportion of eyes with complete resolution of subretinal fluid and/or intraretinal fluid on SD OCT (macular cube) at 24 weeks

Full Information

NCT ID

NCT03071055

First Posted

February 24, 2017

Last Updated

October 19, 2020

Sponsor

Southeast Clinical Research Associates, LLC

Collaborators

Genentech, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03071055

Brief Title

Efficacy of Biweekly Ranibizumab (0.5 mg) for Exudative Macular Degeneration Retinal Edema Refractory to Anti-VEGF

Official Title

Efficacy of Biweekly Ranibizumab (0.5 mg) for Exudative Macular Degeneration Retinal Edema Refractory to Anti-VEGF Therapy Comparing Syringe Preparation Time Using Ranibizumab Vial and Pre-filled Syringe

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Completed

Study Start Date

October 1, 2017 (Actual)

Primary Completion Date

June 3, 2019 (Actual)

Study Completion Date

June 3, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Southeast Clinical Research Associates, LLC

Collaborators

Genentech, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This is a 24 week open label study to assess the efficacy of bi-weekly ranibizumab for patients with retinal fluid due to exudative macular degeneration refractory to monthly therapy.

Detailed Description

This is a 24 week, open-label, non-randomized, phase II study evaluating intravitreal ranibizumab dosed every 14 days in subjects with exudative macular degeneration who have persistent intraretinal or subretinal fluid despite chronic monthly anti-VEGF therapy (>6 months). Subjects must have had a minimum of 5 intravitreal anti-VEGF injections administered every 4-6 weeks in the 6 months preceding enrollment. Consented, enrolled subjects will receive multiple open-label intravitreal injections of 0.5 mg ranibizumab administered every 14 days (± 3 days). Subjects who have resolution of fluid will convert to monthly ranibizumab for the remainder of the study. If fluid recurs, subjects will return to biweekly treatment. Patients will be assigned to receive treatment with either ranibizumab vial or PFSs so that approximately 10 patients will be treated with each delivery method option, and syringe preparation time (SPT) will be measured by an assistant who will be observing the procedure and timing with an automated stopwatch.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Exudative Age Related Macular Degeneration

Keywords

Macular Degeneration, AMD, Wet AMD, Lucentis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ranibizumab

Arm Type

Active Comparator

Arm Description

ranibizumab 0.5mg in commercially available vial

Arm Title

ranibizumab pre filled-syringe

Arm Type

Experimental

Arm Description

ranibizumab 0.5mg in soon to be available pre-filled syringe

Intervention Type

Drug

Intervention Name(s)

Ranibizumab Injection [Lucentis]

Other Intervention Name(s)

Lucentis

Intervention Description

intravitreal injection

Primary Outcome Measure Information:

Title

The primary outcome measure is mean change in ETDRS BCVA visual acuity

Description

The primary outcome measure is mean change in ETDRS BCVA visual acuity at 24 weeks compared to baseline.

Time Frame

24 weeks

Secondary Outcome Measure Information:

Title

Proportion of eyes that gain or lose >0 letters at 24 weeks

Description

Proportion of eyes that gain or lose >0 letters at 24 weeks

Time Frame

24 weeks

Title

Proportion of eyes that gain or lose > 5 letters at 24 weeks

Description

Proportion of eyes that gain or lose > 5 letters at 24 weeks

Time Frame

24 weeks

Title

Proportion of eyes that gain or lose > 10 letters at 24 weeks

Description

Proportion of eyes that gain or lose > 10 letters at 24 weeks

Time Frame

24 weeks

Title

Proportion of eyes that gain or lose > 15 letters at 24 weeks

Description

Proportion of eyes that gain or lose > 15 letters at 24 weeks

Time Frame

24 weeks

Title

To compare syringe preparation time (SPT) using ranibizumab vial and pre-filled syringe (PFS) in a real world clinical setting

Description

To compare syringe preparation time (SPT) using ranibizumab vial and pre-filled syringe (PFS) in a real world clinical setting

Time Frame

24 weeks

Title

• Proportion of eyes with complete resolution of subretinal fluid and/or intraretinal fluid on SD OCT (macular cube) at 24 weeks

Description

• Proportion of eyes with complete resolution of subretinal fluid and/or intraretinal fluid on SD OCT (macular cube) at 24 weeks

Time Frame

24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age > 50 years Exudative age related macular degeneration in study eye involving the fovea Best Corrected Visual Acuity (by ETDRS) letter score in study eye of < 85 and > 24 (approximate Snellen equivalent 20/20 to 20/320) Persistent intraretinal or subretinal fluid on SD OCT despite a minimum of 5 intravitreal anti-VEGF injections administered every 4-6 weeks in the in the 6 months preceding enrollment in the study eye At least 30 days from last intravitreal anti-VEGF injection in the study eye Exclusion Criteria: Patient who are receiving systemic anti-VEGF or proangiogenic therapy Patients on chronic high doses corticosteroid therapy (> than 10 mg of oral prednisone or equivalent greater than 10 days) Patients on chronic immunosuppressant therapy Patients on drugs known to have toxic side effects on the retina e.g. hydroxychloroquine History of intravitreal corticosteroids in study eye within 4 months of baseline Uncontrolled hypertension (defined as systolic >180 mm Hg and/or diastolic > 100 mm Hg while patient is sitting) History of stroke or APTC event in the previous year Any intraocular surgery in study eye within 90 days of baseline Presence of vitreomacular traction in study eye Presence of significant epiretinal proliferation in study eye Evidence of active infection in either eye Uncontrolled glaucoma in the study eye defined as a pressure > 25 mmHg on maximal medical therapy

Facility Information:

Facility Name

Charlotte Eye Ear Nose and Throat Associates, PA

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28210

Country

United States

Facility Name

Charlotte Eye Ear Nose and Throat Associates, PA

City

Statesville

State/Province

North Carolina

ZIP/Postal Code

28677

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Efficacy of Biweekly Ranibizumab (0.5 mg) for Exudative Macular Degeneration Retinal Edema Refractory to Anti-VEGF

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