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Completed

NCT Number: NCT05811351

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)

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Adelaide Eye and Retina Centre, Adelaide, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

JNJ-81201887

Drug

JNJ-81201887 will be administered as intravitreal injection.

Other names: AAVCAGsCD59

Prednisone

Drug

Prednisone will be administered as oral capsule.

Placebo

Other

Prednisone matching placebo will be administered as oral capsule.

Triamcinolone

Drug

Triamcinolone (corticosteroid injection) periocular injection will be administered as per local practice.

Sham Procedure

Other

Sham injections matching to single JNJ-81201887 injection and matching to corticosteroid (triamcinolone) periocular injection will be administered.

Primary outcomes

  1. Global: Change From Baseline in Square Root of Geographic Atrophy (GA) Lesion Area in the Study Eye at Month 18

    Time frame: Baseline and Month 18

    Change from baseline in GA lesion area in the study at month 18 eye will be measured via retinal imaging using fundus auto fluorescence (FAF).

  2. United States (U.S.) Specific: Rate of Change in Untransformed GA Lesion Area in the Study Eye

    Time frame: Baseline to Month 18

    Rate of Change in untransformed GA lesion area in the study eye will be measured via retinal imaging using FAF. A piecewise linear mixed effects (PLME) model will be used for the primary efficacy analysis for rate of change in GA area (GAA) in the study eye.

Secondary outcomes

  1. Change From Baseline in Low Luminance Visual Acuity (LLVA) at Month 18

    Time frame: Baseline and Month 18

    Best corrected LLVA will be assessed using the early treatment diabetic retinopathy study (ETDRS) chart at a starting distance of 4 meter.

  2. Change From Baseline in Reading Speed at Month 18

    Time frame: Baseline and 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.

  3. Change From Baseline in Retinal Sensitivity by Mesopic Microperimetry (MAIA) at Month 18

    Time frame: Baseline and Month 18

    Change from baseline retinal sensitivity by MAIA will be reported.

  4. Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 18

    Time frame: Baseline and Month 18

    Change from baseline in BCVA will be reported and this will be measured using the ETDRS chart at a starting distance of 4 meter.

  5. Change From Baseline in Functional Reading Independence (FRI) Index at Month 18

    Time frame: Baseline and 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.

  6. Change From Baseline in National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25) Composite Score at Month 18

    Time frame: Baseline and 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.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

A Phase 2b, Randomized, Double-masked, Multicenter, Dose-ranging, Sham-controlled Clinical Trial to Evaluate Intravitreal JNJ-81201887 (AAVCAGsCD59) Compared to Sham Procedure for the Treatment of Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 13, 2023
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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