Virus Therapy
Arm B: JNJ-81201887 High dose for Age-Related Macular Degeneration
Retina and Vitreous of Texas, PLLC, Houston, TX
Targeting 2 different conditionsPrednisone +4 morePhase 2RecruitingResearch Sponsored by Janssen Research & Development, LLCEligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Man or woman (according to their reproductive organs and functions assigned by chromosomal complement)
GA can be photographed in its entirety by FAF, using a 30 degree image centered on the fovea
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upbaseline up to 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.
Eligible Conditions
- Age-Related Macular Degeneration
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You are a man or woman based on your reproductive organs and chromosomes.
Select...
FAF has the capability to photograph GA in its entirety with an image centered on the fovea at a 30 degree angle.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to month 18
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 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 up to Month 18
Secondary outcome measures
Change From Baseline in Best Corrected Visual Acuity (BCVA) up to Month 18
Change From Baseline in Functional Reading Independence (FRI) Index up to Month 18
Change From Baseline in Low Luminance Visual Acuity (LLVA) up to 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 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 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 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
Prednisone
2014
Completed Phase 4
~2380
Triamcinolone
2016
Completed Phase 4
~1220
Find a site
Who is running the clinical trial?
Janssen Research & Development, LLCLead Sponsor
952 Previous Clinical Trials
6,375,318 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy Director
Janssen Research & Development, LLC729 Previous Clinical Trials
3,956,950 Total Patients Enrolled
Media Library
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.
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
2
Why did patients apply to this trial?
Not only do I havr.
Patient