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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)

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ClinicalTrials.gov Identifier: NCT05811351
Recruitment Status : Recruiting
First Posted : April 13, 2023
Last Update Posted : December 6, 2023
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Tracking Information
First Submitted Date  ICMJE March 7, 2023
First Posted Date  ICMJE April 13, 2023
Last Update Posted Date December 6, 2023
Actual Study Start Date  ICMJE March 6, 2023
Estimated Primary Completion Date July 16, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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).
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE 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  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Geographic Atrophy
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 31, 2023)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 29, 2026
Estimated Primary Completion Date July 16, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Study Contact 844-434-4210 Participate-In-This-Study@its.jnj.com
Listed Location Countries  ICMJE Australia,   Belgium,   Czechia,   Denmark,   Germany,   Hungary,   Italy,   Netherlands,   Poland,   Portugal,   Spain,   Sweden,   Switzerland,   Turkey,   United Kingdom,   United States
Removed Location Countries Argentina
 
Administrative Information
NCT Number  ICMJE NCT05811351
Other Study ID Numbers  ICMJE 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  ICMJE
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  ICMJE Janssen Research & Development, LLC
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
PRS Account Janssen Research & Development, LLC
Verification Date December 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP