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NCT05769153 · ClinicalTrials.gov registry record · Phase 1

Study of AR-14034 in Participants With Neovascular Age-Related Macular Degeneration (nAMD)

A Phase 1 study of Neovascular Age-related Macular Degeneration (nAMD), sponsored by Alcon Research.

Recruiting
Registry status
Phase 1
Development phase
140
Enrollment target
20
Study locations

NCT05769153: Recruiting Phase 1 study of Neovascular Age-related Macular Degeneration (nAMD), sponsored by Alcon Research.

NCT05769153 is a Phase 1 study of Neovascular Age-related Macular Degeneration (nAMD) that is actively recruiting participants, run by Alcon Research. The registered enrollment target is 140 participants, below the 193-participant average among 9 other Neovascular Age-related Macular Degeneration (nAMD) trials with a reported enrollment target (27% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05769153, a Phase 1 study of Neovascular Age-related Macular Degeneration (nAMD), is actively recruiting participants, sponsored by Alcon Research.

RECRUITING
Registry status
Phase 1
Development phase
140 participants
Enrollment target
20
Study locations

Study Summary

The primary purpose of this study is to evaluate the safety and durability of single- and repeat administration of AR-14034 Sustained Release (SR) in subjects with neovascular age-related macular degeneration (nAMD).

Primary Outcome

Visual acuity will be measured after manifest refraction using Early Treatment of Diabetic Retinopathy Study (ETDRS) letter charts in a 4-meter lane under standard illumination. Best corrected visual acuity (BCVA) will be recorded as the number of letters read correctly. The difference between the average across Weeks 44 and 48, and the baseline visit will be reported. One eye (study eye) will contribute to the analysis.

Conditions Studied

Neovascular Age-related Macular Degeneration (nAMD)

Interventions

  • DRUG AR-14034 SR implant lower dose
  • DRUG AR-14034 SR implant higher dose
  • DRUG AR-14034 SR implant
  • DRUG Aflibercept Injection
  • DRUG Sham procedure

Study Locations (20)

Florida

  • Florida Retina Institute - Jacksonville
  • Mid Florida Eye Center - Mt. Dora
  • Florida Retina Institute - Orlando
  • Retina Specialty Institute - Pensacola
  • Eye Associates of Pinellas - Pinellas Park
  • Center for Retina and Macular Disease - Winter Haven

California

  • The Retina Partners - Encino
  • Retina Associates of Orange County - Laguna Hills
  • Northern California Retina Vitreous Associates Medical Group - Mountain View
  • Eye Research Foundation - Newport Beach
  • Azul Vision Pasadena - Pasadena

Arizona

  • Associated Retina Consultants - Gilbert - Gilbert
  • Associated Retina Consultants - Phoenix - Phoenix
  • Retina Associates of SW PC - Tucson

Georgia

  • Southeast Retina Center - Augusta
  • Thomas Eye Group Main Office - Sandy Springs

Alabama

  • Trinity Research Group - Dothan

Colorado

  • Retina Consultants of Southern Colorado - Colorado Springs

Connecticut

  • Retina Group of New England | Waterford - Waterford

Illinois

  • University Retina and Macula Associates, PC - Oak Forest

Trial Details

FieldValue
Enrollment Target 140 participants
Start Date 2023-12-06
Est. Completion 2027-10
Phase Phase 1
Alcon Research

275 total trials

What NCT05769153 shows while recruiting

NCT05769153 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, below the 193-participant average among 9 other Neovascular Age-related Macular Degeneration (nAMD) trials with a reported enrollment target (27% lower).

The record links to 1 condition, with Neovascular Age-related Macular Degeneration (nAMD) appearing as the primary indexed condition, and to 5 interventions - of which AR-14034 SR implant lower dose is the first listed.

NCT05769153 names 20 study sites across 8 states, led by Florida, California, Arizona.

Frequently Asked Questions

What is clinical trial NCT05769153 about?

NCT05769153 is a clinical study titled "Study of AR-14034 in Participants With Neovascular Age-Related Macular Degeneration (nAMD)". The primary purpose of this study is to evaluate the safety and durability of single- and repeat administration of AR-14034 Sustained Release (SR) in subjects with neovascular age-related macular degeneration (nAMD).

What is the current status of trial NCT05769153?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 140 participants. The study started on 2023-12-06. Estimated completion is 2027-10.

What conditions does trial NCT05769153 study?

This clinical trial studies the following conditions: Neovascular Age-related Macular Degeneration (nAMD).

What interventions are being tested in trial NCT05769153?

The interventions under investigation include: AR-14034 SR implant lower dose (DRUG), AR-14034 SR implant higher dose (DRUG), AR-14034 SR implant (DRUG), Aflibercept Injection (DRUG), Sham procedure (DRUG).

Who is sponsoring clinical trial NCT05769153?

This trial is sponsored by Alcon Research, which has 275 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05769153 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Neovascular Age-related Macular Degeneration (nAMD)

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05769153's enrollment target sits among peer trials

140 7th of 9 higher than 3 of 9 other Neovascular Age-related Macular Degeneration (nAMD) trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Neovascular Age-related Macular Degeneration (nAMD) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT05769153

Source: ClinicalTrials.gov NCT05769153, the US trial registry maintained by the National Library of Medicine. NCT05769153 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.