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Sustained Release Implant
AR-14034 for Age-Related Macular Degeneration (NOVA-1 Trial)
Phase 1 & 2
Recruiting
Research Sponsored by Aerie Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Presence of an active choroidal neovascularization (CNV) lesion secondary to age-related macular degeneration (AMD);
Greater than or equal to 3 and less than or equal to 6 prior treatments of an ocular anti-VEGF medication within the 8 months prior to Screening in the study eye, with demonstrated anatomic response, as assessed by the Investigator.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 44, week 48
Awards & highlights
NOVA-1 Trial Summary
This trial will test a new drug to treat vision loss from age-related macular degeneration.
Who is the study for?
This trial is for people with neovascular age-related macular degeneration (nAMD) who have had 3 to 6 prior anti-VEGF treatments in the last 8 months or are newly diagnosed within 9 months. Participants must have a certain level of vision in both eyes and be able to follow study procedures.Check my eligibility
What is being tested?
The study tests AR-14034 SR implant at two different doses against Aflibercept Injection and a sham procedure, aiming to assess safety and how long the treatment effects last in controlling nAMD.See study design
What are the potential side effects?
While specific side effects aren't listed here, typical risks may include eye irritation, infection risk from injections, potential allergic reactions, and possible changes in vision.
NOVA-1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a specific eye condition due to aging that affects my vision.
Select...
I've had 3-6 eye injections for VEGF in the last 8 months and they worked.
NOVA-1 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 44, week 48
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 44, week 48
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean change from baseline in ETDRS BCVA at the average across two visits, Weeks 44 and 48 (Stage 2)
Secondary outcome measures
Mean change from baseline in Central Subfield Thickness (CST) by visit (Stage 2)
Mean change from baseline in ETDRS BCVA by visit (Stage 2)
NOVA-1 Trial Design
5Treatment groups
Experimental Treatment
Active Control
Group I: Cohort 2 (Stage 1)Experimental Treatment2 Interventions
One IVT injection of aflibercept 2 mg at Week -1 and one IVT insertion of AR-14034 SR higher dose at Baseline. Up to one retreatment with AR-14034 SR will be administered between Weeks 4 and 36 according to protocol-specified disease activity criteria.
Group II: Cohort 1 (Stage 1)Experimental Treatment2 Interventions
One intravitreal (IVT) injection of aflibercept 2 mg at Week -1 and one IVT insertion of AR-14034 SR lower dose at Baseline. Up to one retreatment with AR-14034 SR will be administered between Weeks 4 and 36 according to protocol-specified disease activity criteria.
Group III: AR-14034 SR lower dose (Stage 2)Experimental Treatment3 Interventions
One IVT injection of aflibercept 2 mg at Baseline, Week 4, and Week 8, with one IVT insertion of AR-14034 SR lower dose at Week 6. Up to one retreatment of AR-14034 SR will be administered between Weeks 16 and 52 according to protocol-specified disease activity criteria. Sham procedures will be performed between Weeks 16 and 52 except when AR-14034 SR repeat treatment is administered.
Group IV: AR-14034 SR higher dose (Stage 2)Experimental Treatment3 Interventions
One IVT injection of aflibercept 2 mg at Baseline, Week 4, and Week 8, with one IVT insertion of AR-14034 SR higher dose at Week 6. Up to one retreatment of AR-14034 SR will be administered between Weeks 16 and 52 according to protocol-specified disease activity criteria. Sham procedures will be performed between Weeks 16 and 52 except when AR-14034 SR repeat treatment is administered.
Group V: Aflibercept (Stage 2)Active Control2 Interventions
One IVT injection of aflibercept 2 mg at Baseline, Week 4, Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48. Sham procedures will be performed between Weeks 16 and 52.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aflibercept Injection
2017
Completed Phase 4
~150
Sham procedure
2014
Completed Phase 4
~2510
Find a Location
Who is running the clinical trial?
Alcon ResearchIndustry Sponsor
704 Previous Clinical Trials
124,371 Total Patients Enrolled
Aerie PharmaceuticalsLead Sponsor
38 Previous Clinical Trials
8,186 Total Patients Enrolled
Director of Clinical Development, AlconStudy DirectorAerie Pharmaceuticals
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any available vacancies for this clinical trial?
"Data present on clinicaltrials.gov indicates that this trial is not recruiting participants at the moment, with the listing having been published on December 1st 2023 and most recently updated November 21th of same year. While no longer looking for test subjects, there are 172 other studies actively seeking volunteers presently."
Answered by AI
What is the geographic breadth of this clinical trial?
"This trial is welcoming patients at Retina Specialty Institute in Pensacola, Florida, Retina Vitreous Associates of Florida in Saint Petersburg, Pennsylvania and MidAtlantic Retina Research in Philadelphia, Texas as well as 6 additional clinical sites."
Answered by AI
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