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

Neovascular Age-related Macular Degeneration (nAMD) Clinical Trial

— NOVA-1  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05769153
• Other study ID #: RTE888-E001
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: December 6, 2023
• Est. completion date: March 2027

Study information

• Verified date: February 2024
• Source: Aerie Pharmaceuticals
• Contact: Alcon Call Center
• Phone: 1-888-451-3937
• Email: alcon.medinfo[@]alcon.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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 in both cohorts will 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 lower dose, AR-14034 SR higher dose, 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: March 2027
• Est. primary completion date: March 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Key Inclusion Criteria [Stage 1 and Stage 2]:

• 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 34 letters (approximately 20/200 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.

[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 initial diagnosis of exudative neovascular age-related macular degeneration (nAMD) in the study eye within 9 months before Screening.

Key Exclusion Criteria [Stage 1 and Stage 2]:

• 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 within 28-days before Week -1 [Stage 1] or Baseline [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.

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular Age-related Macular Degeneration (nAMD)
• Wet Macular Degeneration

Intervention

Drug:
• AR-14034 SR implant lower dose
AR-14034 SR administered as an intravitreal implant
• Aflibercept Injection
Aflibercept administered as a 2 milligram (mg) intravitreal injection
• Sham procedure
Needleless syringe used to simulate an intravitreal injection
• AR-14034 SR implant higher dose
AR-14034 SR administered as an intravitreal implant

Locations

Country	Name	City	State
United States	Retina Research Institute of Texas	Abilene	Texas
United States	Northern California Retina Vitreous Associates Medical Group	Mountain View	California
United States	Retina Specialty Institute	Pensacola	Florida
United States	MidAtlantic Retina Research	Philadelphia	Pennsylvania
United States	Retina Vitreous Associates of Florida	Saint Petersburg	Florida
United States	Medical Center Ophthalmology Associates	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Aerie Pharmaceuticals	Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, Week 44, Week 48
Secondary	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.	Baseline to Week 56
Secondary	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.	Baseline to Week 56