A Study to Evaluate Intravitreal JNJ-81201887 (AAVCAGsCD59) Compared to Sham Procedure for the Treatment of Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate change in geographic atrophy (GA) lesion growth of eyes treated with JNJ-81201887 compared to sham control.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm A: JNJ-81201887 Low Dose Participants will receive a single low dose intravitreal injection of JNJ-81201887 in the study eye on Day 4. In addition, participants will receive a 20-day oral prednisone course starting on Day 1 and a single periocular triamcinolone (corticosteroid injection) on Day 4 for prophylaxis of intraocular inflammation. |
Drug: JNJ-81201887
JNJ-81201887 will be administered as intravitreal injection.
Other Names:
Drug: Prednisone
Prednisone will be administered as oral capsule.
Drug: Triamcinolone
Triamcinolone (corticosteroid injection) periocular injection will be administered as per local practice.
|
| Experimental: Arm B: JNJ-81201887 High dose Participants will receive a single high dose intravitreal injection of JNJ-81201887 in the study eye on Day 4. In addition, participants will receive a 20-day oral prednisone course starting on Day 1 and a single periocular triamcinolone (corticosteroid injection) on Day 4 for prophylaxis of intraocular inflammation. |
Drug: JNJ-81201887
JNJ-81201887 will be administered as intravitreal injection.
Other Names:
Drug: Prednisone
Prednisone will be administered as oral capsule.
Drug: Triamcinolone
Triamcinolone (corticosteroid injection) periocular injection will be administered as per local practice.
|
| Sham Comparator: Arm C: Sham Procedure Participants will receive sham procedure that matches the single JNJ21801887 injection on Day 4, a sham procedure that matches the periocular corticosteroid injection (triamcinolone) on Day 4 and a 20-day placebo matching oral prednisone starting on Day 1. |
Other: Placebo
Prednisone matching placebo will be administered as oral capsule.
Other: Sham Procedure
Sham injections matching to single JNJ-81201887 injection and matching to corticosteroid (triamcinolone) periocular injection will be administered.
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline in Square Root of Geographic Atrophy (GA) Lesion Area in the Study Eye up to Month 18 [Baseline up to Month 18]
Change from baseline in GA lesion area in the study eye will be measured via retinal imaging using fundus auto fluorescence (FAF).
Secondary Outcome Measures
- Change From Baseline in Low Luminance Visual Acuity (LLVA) up to Month 18 [Baseline up to Month 18]
Best corrected LLVA will be assessed using the early treatment diabetic retinopathy study (ETDRS) chart at a starting distance of 4 meter.
- Change From Baseline in Reading Speed up to Month 18 [Baseline up to Month 18]
Change from baseline in reading speed (normal luminance) as assessed by Radner reading charts will be performed in the study eye and binocularly for participants who are fluent in the languages available for the Radner Chart will be reported.
- Change From Baseline in Retinal Sensitivity by Mesopic Microperimetry (MAIA) up to Month 18 [Baseline up to Month 18]
Change from baseline retinal sensitivity by MAIA will be reported.
- Change From Baseline in Best Corrected Visual Acuity (BCVA) up to Month 18 [Baseline up to Month 18]
Change from baseline in BCVA will be reported and this will be measured using the ETDRS chart.
- Change From Baseline in Functional Reading Independence (FRI) Index up to Month 18 [Baseline up to Month 18]
The FRI is an interviewer-administered questionnaire with 7 items on functional reading activities most relevant to GA AMD participants. Item scores reflect decreasing levels of functional reading independence. The FRI Index yields continuous mean scores (range 1 to 4), and ordinal-level scores from Level 1 = "Unable to do" to Level 4 = "Totally independent." For each FRI Index reading activity performed in the past 7 days, participants are asked about the extent to which they required vision aids, adjustments in the activity, or help from another person.
- Change From Baseline in National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) Composite Score up to Month 18 [Baseline up to Month 18]
The 2000 version of the NEI-VFQ-25, which must be interviewer-administered, includes 25 items and is scored to produce 11 subscales and a general health item. The 11 subscales include General Vision (1 item), Ocular Pain (2 items), Near Activities (3 items), Distance Activities (3 items), Social Functioning (2 items), Mental Health (2 items), Role Difficulties (2 items), Dependency (3 items), Driving (3 items), Color Vision (1 item), and Peripheral Vision (1 item). Response to each question converted to 0-100 score. Each subscale, total score equal to (=) average of items contributing to score. For each subscale and total score, score range: 0 to 100, higher score equal to less symptoms/better visual functioning.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Have non-subfoveal (defined as not involving the center point of the fovea) geographic atrophy (GA) secondary to age-related macular degeneration (AMD) with an area measuring 2.5 millimeter square (mm2) to 17.5 mm2 (1 and 7 disc areas respectively), determined by the central reading center (CRC) from screening images of fundus autofluorescence (FAF) and spectral domain optical coherence tomography (SD-OCT)
-
If GA is multifocal, at least one focal lesion must be greater than or equal to (>=) 1.25 mm^2 (0.5 disc area)
-
GA can be photographed in its entirety by FAF, using a 30 degree image centered on the fovea
-
Fellow eye must be present with a best corrected distance visual acuity (BCVA) of counting fingers or better
-
Man or woman (according to their reproductive organs and functions assigned by chromosomal complement)
Exclusion Criteria:
-
History of transpupillary thermotherapy, photodynamic therapy or external-beam radiation therapy in the region of study eye
-
Any prior thermal laser in the macular region, regardless of indication
-
History of retinal detachment (with or without repair)
-
Active, infectious conjunctivitis, keratitis, scleritis, or endophthalmitis
-
Any sign of diabetic retinopathy or central serous chorioretinopathy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Retinal Research Institute | Phoenix | Arizona | United States | 85053 |
| 2 | Retina Consultants San Diego | Poway | California | United States | 92064 |
| 3 | University Retina | Lemont | Illinois | United States | 60439 |
| 4 | Cumberland Valley Retina Consultants | Hagerstown | Maryland | United States | 21740 |
Sponsors and Collaborators
- Janssen Research & Development, LLC
Investigators
- Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CR109236
- 81201887MDG2001
- 2022-500746-16-00