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Neovascular Age-related Macular Degeneration (nAMD)Phase 1/2NOVA-1NCT05769153

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

A Phase 1/2 study testing AR-14034 SR implant lower dose, AR-14034 SR implant higher dose and AR-14034 SR implant in people with Neovascular Age-related Macular Degeneration (nAMD), run by Alcon Research at 42 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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). Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
AR-14034 SR implant lower dose, AR-14034 SR implant higher dose and AR-14034 SR implant
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
139 participants
Where
42 sitesUnited States
Study dates
6 Dec 2023to Sep 2027
Phase
Phase 1/2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Presence of an active choroidal neovascularization (CNV) lesion secondary to age-related macular degeneration (AMD);
  • Best corrected visual acuity (BCVA) between 80 and 35 letters (20/25 to 20/200 Snellen equivalent) in the study eye;
  • BCVA greater than 20 letters (approximately 20/400 Snellen equivalent) in the non-study eye;
  • Media clarity and pupillary dilation in the study eye sufficient for all planned study procedures;
  • Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol;
  • Other protocol-specified inclusion criteria may apply.
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  • [Stage 1]:
  • 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.
  • [Stage 2]:
  • Treatment-naïve, or diagnosis of exudative neovascular age-related macular degeneration (nAMD) in the study eye.

Who cannot join

  • History or current ocular disease in the study eye other than nAMD, that, might require medical or surgical intervention during the study;
  • Structural damage to the macula that is likely to preclude improvement in visual acuity in the study eye after resolution of the nAMD;
  • Any active intraocular or periocular infection or active intraocular inflammation;
  • Treatment with ocular anti-VEGF product in the study eye within 28 days before Week 1 [Stage 1] or within 56 days before Screening [Stage 2].
  • Uncontrolled glaucoma in the study eye;
  • Uncontrolled blood pressure;
  • Females of child-bearing potential who are pregnant, intending to become pregnant, nursing, or who are not willing to use an acceptable form of contraception for the duration of the study;
  • Other protocol-specified exclusion criteria may apply.

Trial locations and contacts

42 sites in 1 country.

42 sites in 1 country

United States42 sites

  • Retina Research Institute of Texas

    Abilene, Texas, 79606

  • Vision Research Center Eye Associates of New Mexico

    Albuquerque, New Mexico, 87109

  • Texas Retina Associates - Arlington

    Arlington, Texas, 76012

  • Southeast Retina Center

    Augusta, Georgia, 30909

  • Austin Research Center for Retina

    Austin, Texas, 78705

  • Austin Retina Associates

    Austin, Texas, 78705

  • Austin Clinical Research, LLC

    Austin, Texas, 78750

  • Star Vision Research

    Burleson, Texas, 76028

  • Pacific Northwest Retina

    Burlington, Washington, 98233

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • Retina Consultants of Southern Colorado

    Colorado Springs, Colorado, 80809

  • Twin Cities Eye Consultants

    Coon Rapids, Minnesota, 55433

  • Texas Retina Associates

    Dallas, Texas, 75231

  • Trinity Research Group

    Dothan, Alabama, 36301

  • The Retina Partners

    Encino, California, 91436

  • Erie Retina Research

    Erie, Pennsylvania, 16507

  • Verum Research, LLC

    Eugene, Oregon, 97401

  • NYC Retina - Queens

    Forest Hills, New York, 11375

  • Associated Retina Consultants - Gilbert

    Gilbert, Arizona, 85297

  • Retina Consultants of Carolina

    Greenville, South Carolina, 29605

  • Berkeley Eye Center

    Houston, Texas, 77027

  • Florida Retina Institute

    Jacksonville, Florida, 32216

  • Retina Associates of Orange County

    Laguna Hills, California, 92653

  • Mississippi Retina Associates

    Madison, Mississippi, 39110

  • Northern California Retina Vitreous Associates Medical Group

    Mountain View, California, 94040

  • Mid Florida Eye Center

    Mt. Dora, Florida, 32757

  • Carolina Eyecare Physicians LLC

    Mt. Pleasant, South Carolina, 29464

  • Eye Research Foundation

    Newport Beach, California, 92663

  • University Retina and Macula Associates, PC

    Oak Forest, Illinois, 60452

  • Florida Retina Institute

    Orlando, Florida, 32806

  • Azul Vision Pasadena

    Pasadena, California, 99107

  • Retina Specialty Institute

    Pensacola, Florida, 32503

  • MidAtlantic Retina Research

    Philadelphia, Pennsylvania, 19107

  • Associated Retina Consultants - Phoenix

    Phoenix, Arizona, 85020

  • Eye Associates of Pinellas

    Pinellas Park, Florida, 33782

  • Retina Consultants of Texas - San Antonio

    San Antonio, Texas, 78251

  • Austin Retina Associates (San Marcos)

    San Marcos, Texas, 78666

  • Thomas Eye Group Main Office

    Sandy Springs, Georgia, 30328

  • Retina Research Center of Southern Utah

    St. George, Utah, 84790

  • Retina Associates of SW PC

    Tucson, Arizona, 85704

  • Retina Group of New England | Waterford

    Waterford, Connecticut, 06385

  • Center for Retina and Macular Disease

    Winter Haven, Florida, 33880

Other trials in United States

About this study

Official title: A Phase 1/2 Two-Stage Dose Escalation and Randomized Parallel-Group Study to Evaluate the Safety, Preliminary Treatment Effects, and Durability of AR-14034 Sustained Release Implant Compared to Intravitreal Anti-Vascular Endothelial Growth Factor Treatment in Participants With Neovascular Age-Related Macular Degeneration

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).

Read the detailed description

This study will be conducted in two stages. Stage 1 is a 48-week, dose-escalation, open-label evaluation of AR-14034 SR. Two cohorts will be enrolled, for an approximate total of 10 subjects. Subjects will receive AR-14034 SR in one of two dose levels and attend visits through Week 48 for assessment of safety and preliminary treatment effects.

Stage 2 is a 56-week (plus extension) double-masked, active comparator, randomized, parallel group evaluation of AR-14034 SR compared with aflibercept. Approximately 130 subjects will be enrolled and randomized 2:2:1 to AR-14034 SR one injection, AR-14034 SR two injections, or aflibercept dosed as labelled. Subjects will attend visits through Week 56 for assessment of safety and treatment effects. A 16-week open label extension phase will be conducted thereafter.

Being tested
AR-14034 SR implant lower dose, AR-14034 SR implant higher dose, AR-14034 SR implant, Aflibercept Injection, Sham procedure
Keywords
nAMD, retina, eyes, ophthalmology

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AR-14034 SR implant lower doseDrug

    AR-14034 SR administered as an intravitreal implant

  • AR-14034 SR implant higher doseDrug

    AR-14034 SR administered as an intravitreal implant

  • AR-14034 SR implantDrug

    AR-14034 SR administered as an intravitreal implant

  • Aflibercept InjectionDrug

    Aflibercept administered as a 2 milligram (mg) intravitreal injection

  • Sham procedureDrug

    Needleless syringe used to simulate an intravitreal injection

Study groups in NCT05769153
Study groupRoleWhat they receive
Cohort 1 (Stage 1)ExperimentalOne 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.
Receives: Drug: AR-14034 SR implant lower dose; Drug: Aflibercept Injection
Cohort 2 (Stage 1)ExperimentalOne 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.
Receives: Drug: AR-14034 SR implant higher dose; Drug: Aflibercept Injection
AR-14034 SR one injection (Stage 2)ExperimentalOne IVT injection of aflibercept 2 mg at Baseline, Week 4, and Week 8, with one IVT insertion of AR-14034 SR at Week 2. Sham procedures will be performed between Baseline and Week 52 when other arms are receiving scheduled treatment injections.
Receives: Drug: AR-14034 SR implant; Drug: Aflibercept Injection; Drug: Sham procedure
AR-14034 SR two injections (Stage 2)ExperimentalOne IVT injection of aflibercept 2 mg at Baseline, Week 4, and Week 8, with IVT insertions of AR-14034 SR at Week 2 and Week 6. Sham procedures will be performed between Baseline and Week 52 when other arms are receiving scheduled treatment injections.
Receives: Drug: AR-14034 SR implant; Drug: Aflibercept Injection; Drug: Sham procedure
Aflibercept (Stage 2)Active comparatorOne 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 Baseline and Week 52 when other arms are receiving scheduled treatment injections.
Receives: Drug: Aflibercept Injection; Drug: Sham procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: Baseline, Week 44, Week 48

Secondary outcomes (2)

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

    Visual acuity will be measured after manifest refraction using ETDRS letter charts in a 4-meter lane under standard illumination. BCVA will be recorded as the number of letters read correctly. The difference between a given post-baseline visit and the baseline visit will be reported. One eye (study eye) will contribute to the analysis.

    Measured: Baseline to Week 56

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

    Central subfield thickness (CST) will be assessed using spectral domain optical coherence tomography (SD-OCT) imaging and measured in micrometers. The difference between a given post-baseline visit and the baseline visit will be reported. One eye (study eye) will contribute to the analysis.

    Measured: Baseline to Week 56

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2023
  2. Study start6 Dec 2023
  3. Primary completionApr 2027 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Stage 1 will enroll 2 cohorts. Stage 2 will enroll 3 treatment arms.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
139 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05769153
Sponsor's protocol ID
RTE888-E001
Acronym
NOVA-1
Status last verified
Aug 2026
First submitted
3 Mar 2023
Last updated
27 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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