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)

Janssen (J&J Innovative Medicine)

Status and phase: Enrolling; Phase 2

Conditions: Geographic Atrophy

Treatments: Drug: Triamcinolone; Other: Sham Procedure; Other: Placebo; Drug: Prednisone; Drug: JNJ-81201887

Study type: Interventional

Funder types: Industry

Identifiers

NCT05811351

81201887MDG2001 (Other Identifier)

2022-500746-16-00 (Registry Identifier)

CR109236

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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 that can be measured and measures 2.5 millimeter square (mm^2) to 17.5 mm^2 (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), as assessed by the CRC
• GA can be photographed in its entirety by FAF, using a 30- degree image centered on the fovea, as assessed by the CRC
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

300 participants in 3 patient groups

Arm A: JNJ-81201887 Low Dose

Experimental group

Description:

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, long acting periocular triamcinolone (corticosteroid injection) on Day 4 for prophylaxis of intraocular inflammation.

Treatment:

Drug: JNJ-81201887

Drug: Prednisone

Drug: Triamcinolone

Arm B: JNJ-81201887 High dose

Experimental group

Description:

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, long acting periocular triamcinolone (corticosteroid injection) on Day 4 for prophylaxis of intraocular inflammation.

Treatment:

Drug: JNJ-81201887

Drug: Prednisone

Drug: Triamcinolone

Arm C: Sham Procedure

Sham Comparator group

Description:

Participants will receive sham procedure that matches the single JNJ21801887 injection on Day 4, a sham procedure that matches the long acting periocular corticosteroid injection (triamcinolone) on Day 4 and a 20-day placebo matching oral prednisone starting on Day 1.

Treatment:

Other: Placebo

Other: Sham Procedure