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Sustained Release Implant

AR-14034 for Age-Related Macular Degeneration (NOVA-1 Trial)

Phase 1 & 2

Recruiting

Research Sponsored by Alcon Research

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

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a specific eye condition due to aging that affects my vision.

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I've had 3-6 eye injections for VEGF in the last 8 months and they worked.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 44, week 48 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean change from baseline in ETDRS BCVA at the average across two visits, Weeks 44 and 48 (Stage 2)

Secondary study objectives

Mean change from baseline in Central Subfield Thickness (CST) by visit (Stage 2)

Mean change from baseline in ETDRS BCVA by visit (Stage 2)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

2019

Completed Phase 4

~180

Sham procedure

2014

Completed Phase 4

~2510