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The trial is taking place at:
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Retina Specialty Institute | Pensacola, FL

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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) logo

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

Trial contacts and locations

161

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Central trial contact

Study Contact

Data sourced from clinicaltrials.gov

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