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Virus Therapy
JNJ-81201887 for Geographic Atrophy Due to Age-Related Macular Degeneration
Phase 2
Recruiting
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and month 18
Awards & highlights
Study Summary
This trial tested if a drug could help slow growth of eye damage caused by a disease called geographic atrophy.
Who is the study for?
This trial is for adults with a specific eye condition called non-subfoveal geographic atrophy due to age-related macular degeneration. The affected area must be visible and measurable, and their other eye should have minimal vision of counting fingers or better. People with active eye infections, certain retinal diseases, previous specific treatments in the study eye region, or history of retinal detachment cannot participate.Check my eligibility
What is being tested?
The trial is testing JNJ-81201887, an investigational drug delivered into the eye (intravitreal injection), against a sham procedure (a fake treatment that mimics the real procedure without delivering medication) to see if it slows down lesion growth in patients with geographic atrophy.See study design
What are the potential side effects?
Potential side effects may include discomfort from injections like redness or pain at the injection site, increased risk of infection inside the eye (endophthalmitis), possible inflammation within the eye structures, and elevated pressure inside the eyeball.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and month 18
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and month 18
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change From Baseline in Square Root of Geographic Atrophy (GA) Lesion Area in the Study Eye at Month 18
Secondary outcome measures
Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 18
Change From Baseline in Functional Reading Independence (FRI) Index at Month 18
Change From Baseline in Low Luminance Visual Acuity (LLVA) at Month 18
+3 moreTrial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm B: JNJ-81201887 High doseExperimental Treatment3 Interventions
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.
Group II: Arm A: JNJ-81201887 Low DoseExperimental Treatment3 Interventions
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.
Group III: Arm C: Sham ProcedurePlacebo Group2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Triamcinolone
2016
Completed Phase 4
~1220
Prednisone
2014
Completed Phase 4
~2370
Find a Location
Who is running the clinical trial?
Janssen Research & Development, LLCLead Sponsor
976 Previous Clinical Trials
6,384,392 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
746 Previous Clinical Trials
3,959,978 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have an active eye infection.I have had laser treatment in the macula area of my eye.I have had specific eye treatments in the area of my study eye.I have had a retinal detachment in the past.FAF has the capability to photograph GA in its entirety with an image centered on the fovea at a 30 degree angle.One of my eye lesions is larger than 1.25 mm^2.I am biologically male or female.I have signs of eye damage due to diabetes or a specific retinal condition.My eye condition is due to AMD and affects a specific area of my retina.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B: JNJ-81201887 High dose
- Group 2: Arm C: Sham Procedure
- Group 3: Arm A: JNJ-81201887 Low Dose
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the enrolment quota for this research project?
"For the successful completion of this study, a total of 300 participants must meet the study's criteria. The sponsor, Janssen Research & Development LLC is managing this project at Retina Consultants San Diego in Poway California and University Retina in Lemont Illinois along with other sites."
Answered by AI
How many locations are conducting this scientific experiment?
"Currently, 4 medical sites are enlisting patients for this trial. The locales can be found in Poway and Lemont as well as Hagerstown with other neighbouring areas offering participation too. Choosing the closest location may help reduce any transportation needs if you decide to join the study."
Answered by AI
What regulatory status has been granted to Arm A's JNJ-81201887 Low Dose?
"Our experts at Power gave Arm A: JNJ-81201887 Low Dose a rating of 2, as it is currently undergoing Phase 2 trials and has evidence attesting to its safety but not efficacy."
Answered by AI
Are there still opportunities for enrolment in this medical experiment?
"According to the clinicaltrials.gov portal, this clinical trial is still open for enrolment; it was originally posted on March 6th 2023 and recently updated on March 31st 2023."
Answered by AI
Who else is applying?
What state do they live in?
Texas
Ohio
What site did they apply to?
Midwest Eye Institute
Cincinnati Eye Institute
Retina Associates of South Texas, P.A.
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
1
2
Why did patients apply to this trial?
Not only do I havr. I am currently receiving Eylea every 3 months and have developed geographical atrophy. My vision was controlled with the Eylea but has deteriorated in recent months to a point that I cannot drive, cannot read and have difficulty using a computer.
PatientReceived 2+ prior treatments
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