ClinicalTrials.gg
RecruitingNCT06635148Updated Nov 3, 2026

A Long-term Extension Study of JNJ-81201887 (AAVCAGsCD59) Parent Studies in Participants With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)

A Phase 2/3 interventional study of JNJ-81201887 and Sham Procedure in Geographic Atrophy and Macular Degeneration, sponsored by Janssen Research & Development, LLC. Recruiting at 104 sites in 18 countries. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by Janssen Research & Development, LLC (part of Johnson & Johnson) · Phase 2/3, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2024; still recruiting 2 years 1 month later.
Updated Nov 3, 2026Site recruiting status changedPrimary outcomes revisedGo to Updates ↓
Phase
Phase 2/3
Study type
Interventional
Enrollment
274
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Study summary

The purpose of this study is to assess the long-term safety and tolerability after an intravitreal injection (a shot of medicine into the eye) of JNJ-81201887 administered in parent clinical studies.

02

Conditions studied

  • Geographic Atrophy
  • Macular Degeneration
03

In context

Geographic Atrophy

188 studies on the registry are indexed under Geographic Atrophy; 52 are open to participants now.

This study's planned enrollment of 274 is above the median of 70 across 141 interventional studies indexed under Geographic Atrophy.

Browse Geographic Atrophy studies →

Lead sponsor

Janssen Research & Development, LLC is the lead sponsor of 932 studies on the registry; 76 are open to participants now.

Of its 285 completed or terminated interventional studies of FDA-regulated products, 136 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participants who were enrolled and received treatment with JNJ-81201887 or sham in a parent clinical study (81201887MDG2001, 81201887MDG1003)
  • Females (women of ), male participants, and partners of male participants will not be required to use in this LTE study
  • Must sign an form (ICF) indicating that participant understands the purpose of, and procedures required for, the study and is willing to participate in the study. The ICF may be signed by an impartial witness and/or legally designated representative depending on national/local regulations

Exclusion criteria

Exclusion Criteria:

  • There are no exclusion criteria for this LTE study
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
274 participants (estimated)

Study arms

  • Experimental
    Arm A: JNJ-81201887 Low Dose

    Study participants who were enrolled and received treatment with low dose JNJ-81201887 in parent clinical studies (81201887MDG2001 \[NCT05811351\]; 81201887MDG1003) will enter this long-term extension (LTE) study. No study intervention will be administered as part of this study.

    Drug: JNJ-81201887

  • Experimental
    Arm B: JNJ-81201887 High dose

    Study participants who were enrolled and received treatment with high dose JNJ-81201887 in parent clinical studies (81201887MDG2001 \[NCT05811351\]; 81201887MDG1003) will enter this LTE study. No study intervention will be administered as part of this study.

    Drug: JNJ-81201887

  • Sham comparator
    Arm C: Sham Procedure

    Participants randomized to the sham arm in parent study 81201887MDG2001 (NCT05811351) will enter this LTE study. No intervention will be administered as part of this study.

    Other: Sham Procedure

Interventions

  • No study intervention will be administered as part of this LTE study.

  • OtherSham Procedure

    No study intervention will be administered as part of this LTE study.

06

What researchers measure

Primary outcomes

  1. Number of Participants with Ocular and Systemic Treatment-emergent Adverse Events (TEAEs)

    Number of participants with ocular and systemic TEAEs will be reported. An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are defined as any adverse event occurring at or after the administration of study intervention.

    Time frame: Upto 5 Years

  2. Number of Participants with Abnormal Findings in Clinical Laboratory Assessments

    Number of participants with abnormal findings in clinical laboratory Assessments (including hematology and clinical chemistry) will be reported.

    Time frame: Upto 5 Years

  3. Number of Participants with Abnormal Findings in Retinal imaging and Eye Examinations

    Number of participants with abnormal findings in retinal imaging (Fundus Autofluorescence, Spectral Domain Optical Coherence Tomography) and eye examinations will be reported.

    Time frame: Upto 5 Years

  4. Change from Baseline in Best Corrected Visual Acuity (BCVA) Using Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score

    BCVA will be assessed using the ETDRS chart at a starting distance of 4 meters. The ETDRS score ranges from 0 to 100 letters, where an increase in the number of letters read correctly means that visual acuity has improved and vice-versa.

    Time frame: Baseline up to 42 months

07

Study locations

85 of 104 sites recruiting

Showing the first 100 of 104 sites across 18 countries. Choose a country and city above to see the rest.

08

References and documents

Individual participant data

Plan to share: Yes — The data sharing policy of Johnson \& Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/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

Data sharing details ↗ · www.jnj.com

No publications or documents are linked to this record.

09

Updates

2 registry updates since Sep 25, 2026
Sites
2 sites changed recruiting status (2 now active, not recruiting)
Show 2 sites
  • Fakultni nemocnice Kralovske Vinohrady · Prague, CzechiaRecruiting→Active, not recruiting
  • AXON Clinical s.r.o. · Prague, CzechiaRecruiting→Active, not recruiting
Nov 3, 2026
Primary outcomes
1 description edited
What changed in the outcomes
  • DescriptionChange from Baseline in Best Corrected Visual Acuity (BCVA) Using Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score: how it is measured was reworded
Sep 30, 2026
Show all 2 updates
  1. Nov 3, 2026
    2 sites changed recruiting status (2 now active, not recruiting)
    Show 2 sites
    • Fakultni nemocnice Kralovske Vinohrady · Prague, CzechiaRecruiting→Active, not recruiting
    • AXON Clinical s.r.o. · Prague, CzechiaRecruiting→Active, not recruiting
    + 1 other change: verification date
  2. Sep 30, 2026
    Primary outcomes 1 description edited
    What changed in the outcomes
    • DescriptionChange from Baseline in Best Corrected Visual Acuity (BCVA) Using Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score: how it is measured was reworded
    + 2 other changes: oversight details and design details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06635148
Responsible party
Sponsor
First posted
Oct 10, 2024
Start date
Sep 19, 2024
Primary completion
Aug 24, 2029 (estimated)
Completion
Jul 16, 2030 (estimated)
Last update
Nov 3, 2026

Study contacts

Study Contact
Contact
Participate-In-This-Study1@its.jnj.com
844-434-4210
Janssen Research & Development, LLC Clinical Trial
study director · Janssen Research & Development, LLC

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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