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)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Janssen - Cilag International

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Eye Diseases [C11]

Trial duration

11 Aug 2023 → 23 Feb 2026

Decision date (initial)

2023-07-19

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Janssen Research & Development, LLC

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Others, Safety

Change in GA lesion growth of eyes treated with JNJ-81201887 compared to sham control

Conditions and MedDRA coding

Geographic Atrophy

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

Yes

IPD 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

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. 1. 60 years of age or older
2. 2. Have non-subfoveal (defined as not involving the center point of the fovea) GA secondary to AMD with an area that can be measured and measures 2.5 mm2 to 17.5 mm2 (1- and 7- disc areas respectively), determined by the CRC from screening images of FAF and SD-OCT.
3. 3. A woman of childbearing potential must have a negative highly sensitive serum (β-human chorionic gonadotropin) test for the sample collected at Screening and negative urine pregnancy test on Day 4 before receiving the study intervention.
4. 4. Must sign an ICF indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in and able to complete all required assessments during the study. The ICF may be signed by an impartial witness and/or legally authorized representative depending on national/local regulations.

Exclusion criteria 4

1. 1. History of or presence of retinal disease other than GA for example: diabetic retinopathy, macular edema, central serous chorioretinopathy, inherited retinal degeneration, toxic maculopathies (ie, hydroxychloroquine maculopathy), arterial and venous occlusive disease, macular hole that is present or has been previously repaired, or choroidal melanoma or other retinal diseases that in the opinion of the Investigator, could affect the safety of the participant or interpretation of test results during the course of the study.
2. 3. History of transpupillary thermotherapy, photodynamic therapy or external-beam radiation therapy in the region of study eye.
3. 4. Any prior thermal laser in the macular region, regardless of indication.
4. 2. Presence of macular fibrosis or retinal epithelial tear, clinically relevant myopic degeneration, or vitreous hemorrhage a. Benign conditions of the vitreous (e.g, posterior vitreous detachment) or peripheral retina (e.g, paving stone degeneration, lattice degeneration, etc.) are permitted.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change in square root GA lesion area in the study eye measured on fundus autofluorescence (FAF)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 5

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Janssen - Cilag International

Sponsor organisation

Janssen - Cilag International

Address

Turnhoutseweg 30

City

Beerse

Postcode

2340

Country

Belgium

Scientific contact point

Organisation

Janssen - Cilag International

Contact name

CTIS Point of Contact

Public contact point

Organisation

Janssen - Cilag International

Contact name

CTIS Point of Contact

Third parties 7

Locations

11 EU/EEA countries · 59 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Corrective measures 1 · Art. 77 CTR

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 265 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

21 submissions — initial application plus substantial / non-substantial modifications