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)

• ClinicalTrials.gov Identifier: NCT05811351
• Recruitment Status: Recruiting
• First Posted: April 13, 2023
• Last Update Posted: April 24, 2024
• Sponsor: Janssen Research & Development, LLC
• Information provided by (Responsible Party): Janssen Research & Development, LLC

Tracking Information

• First Submitted Date: March 7, 2023
• First Posted Date: April 13, 2023
• Last Update Posted Date: April 24, 2024
• Actual Study Start Date: March 6, 2023
• Estimated Primary Completion Date: July 16, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 26, 2023)

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).

Original Primary Outcome Measures (submitted: March 31, 2023)

Change From Baseline in Square Root of Geographic Atrophy (GA) Lesion Area in the Study Eye up to Month 18 [ Time Frame: 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).

Current Secondary Outcome Measures (submitted: October 26, 2023)

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Original Secondary Outcome Measures (submitted: March 31, 2023)

• Change From Baseline in Low Luminance Visual Acuity (LLVA) up to Month 18 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief 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)
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Geographic Atrophy

Intervention

• Drug: JNJ-81201887
  JNJ-81201887 will be administered as intravitreal injection.
  Other Name: AAVCAGsCD59
• Drug: Prednisone
  Prednisone will be administered as oral capsule.
• Other: Placebo
  Prednisone matching placebo will be administered as oral capsule.
• Drug: Triamcinolone
  Triamcinolone (corticosteroid injection) periocular injection will be administered as per local practice.
• Other: Sham Procedure
  Sham injections matching to single JNJ-81201887 injection and matching to corticosteroid (triamcinolone) periocular injection will be administered.

Study Arms

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

  • Drug: JNJ-81201887
  • Drug: Prednisone
  • Drug: Triamcinolone
• 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, long acting periocular triamcinolone (corticosteroid injection) on Day 4 for prophylaxis of intraocular inflammation.
  Interventions:

  • Drug: JNJ-81201887
  • Drug: Prednisone
  • Drug: Triamcinolone
• 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 long acting periocular corticosteroid injection (triamcinolone) on Day 4 and a 20-day placebo matching oral prednisone starting on Day 1.
  Interventions:

  • Other: Placebo
  • Other: Sham Procedure

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: March 31, 2023): 300
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 8, 2026
• Estimated Primary Completion Date: July 16, 2025 (Final data collection date for primary outcome measure)

Eligibility 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 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 60 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Study Contact; 844-434-4210; Participate-In-This-Study@its.jnj.com

• Listed Location Countries: Australia, Belgium, Canada, Czechia, Denmark, Germany, Hungary, Italy, Netherlands, Poland, Portugal, Spain, Sweden, Switzerland, Turkey, United Kingdom, United States
• Removed Location Countries: Argentina

Administrative Information

• NCT Number: NCT05811351
• Other Study ID Numbers: CR109236; 81201887MDG2001 ( Other Identifier: Janssen Research & Development, LLC ); 2022-500746-16-00 ( Registry Identifier: EUCT number )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
• URL: https://www.janssen.com/clinical-trials/transparency

• Current Responsible Party: Janssen Research & Development, LLC
• Original Responsible Party: Same as current
• Current Study Sponsor: Janssen Research & Development, LLC
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Janssen Research & Development, LLC Clinical Trial; Janssen Research & Development, LLC

• PRS Account: Janssen Research & Development, LLC
• Verification Date: April 2024