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)

Phase
Recruitment status
Participants
Lead sponsor
Janssen Research & Development, LLC
Start date
Number of sites

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.
Short title
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)
Official 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)

Control arm
Registry reports results
Listing at source
Recruitment status
Phase
Study type
Interventional

Completion date
First posted
Registry last updated
Primary completion date
Start date

Actual participants
Participants
Participant count basis
Protocol amendments
Number of sites

Data monitoring committee
Registry sponsor category
Lead sponsor
Janssen Research & Development, LLC
Source registry
ClinicalTrials.gov

Registry ID
ClinicalTrials.gov ID
Registry record
Open registry record

Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Triple masking
Masked roles
Participants, Investigators, Outcome assessors
Sources for study design

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

    Timeframe: 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

    Timeframe: 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.

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

    Timeframe: 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

    Timeframe: 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

    Timeframe: 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

    Timeframe: 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

    Timeframe: 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

    Timeframe: 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.

Sources for outcomes

Sex
All
Age groups
Adults, Older adults
Minimum age
60 Years
Healthy volunteers
No

  • 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)

  • 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
Sources for eligibility

  • Retinal Research InstitutePhoenix, United States
  • Retina Associates Southwest PCTucson, United States
  • Retina Consultants of Orange CountyFullerton, United States
  • Retina Associates Of Southern CaliforniaHuntington Beach, United States
  • Shiley Eye Institute Jacobs Retina CenterLa Jolla, United States
  • Jules Stein Eye Institute UCLALos Angeles, United States
  • The Retina PartnersLos Angeles, United States
  • California Retina ConsultantsOxnard, United States
  • Stanford Health CarePalo Alto, United States
  • California Eye Medical SpecialistsPasadena, United States
  • Retina Consultants San DiegoPoway, United States
  • Retina Consultants of Southern CaliforniaRedlands, United States
  • Bay Area Retina AssociatesWalnut Creek, United States
  • Colorado Retina - Lakewood ClinicLakewood, United States
  • Retina Group of FloridaFort Lauderdale, United States
  • National Opthalmic Research InstituteFort Myers, United States
  • VitreoRetinal Associates, PAGainesville, United States
  • MedEye AssociatesMiami, United States
  • Retina Specialty InstitutePensacola, United States
  • Fort Lauderdale Eye InstitutePlantation, United States
  • Retina Vitreous Associates of FloridaSt. Petersburg, United States
  • East Florida Eye InstituteStuart, United States
  • Georgia RetinaMarietta, United States
  • Marietta Eye ClinicMarietta, United States
  • University Of IllinoisChicago, United States

And 137 more, listed on the interactive page.

Sources for sites

  • 2022-500746-16-00
  • 81201887MDG2001
Sources for references

Related records

Drugs (2)

Lead sponsors (1)

Conditions (1)

Targets (1)