Clinical trial NCT05769153: Study of AR-14034 in Participants With Neovascular Age-Related Macular Degeneration (nAMD)
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Neovascular Age-related Macular Degeneration (nAMD)
Keywords: nAMD
retina
eyes
ophthalmology
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2023-03-15
Enrollment: 140
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Stage 1 will enroll 2 cohorts. Stage 2 will enroll 3 treatment arms.
Primary purpose: TREATMENT

Brief 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).

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mean change from baseline in ETDRS BCVA at the average across two visits, Weeks 44 and 48 (Stage 2)
timeFrame: Baseline, Week 44, Week 48
Secondary outcomes:
measure: Mean change from baseline in ETDRS BCVA by visit (Stage 2)
timeFrame: Baseline to Week 56
measure: Mean change from baseline in Central Subfield Thickness (CST) by visit (Stage 2)
timeFrame: Baseline to Week 56
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Trinity Research Group
state: Alabama
city: Gilbert
country: United States
facility: Associated Retina Consultants - Gilbert
state: Arizona
city: Phoenix
country: United States
facility: Associated Retina Consultants - Phoenix
state: Arizona
city: Tucson
country: United States
facility: Retina Associates of SW PC
state: Arizona
city: Laguna Hills
country: United States
facility: Retina Associates of Orange County
state: California
city: Mountain View
country: United States
facility: Northern California Retina Vitreous Associates Medical Group
state: California
city: Sacramento
country: United States
facility: Retinal Consultants Medical Group, Inc.
state: California
city: Colorado Springs
country: United States
facility: Retina Consultants of Southern Colorado
state: Colorado
city: Clearwater
country: United States
facility: Blue Ocean Clinical Research Center
state: Florida
city: Orlando
country: United States
facility: Florida Retina Institute
state: Florida
city: Pensacola
country: United States
facility: Retina Specialty Institute
state: Florida
city: Pinellas Park
country: United States
facility: Eye Associates of Pinellas
state: Florida
city: Winter Haven
country: United States
facility: Center for Retina and Macular Disease
state: Florida
city: Sandy Springs
country: United States
facility: Thomas Eye Group
state: Georgia
city: Oak Forest
country: United States
facility: University Retina and Macula Associates, PC
state: Illinois
city: Hagerstown
country: United States
facility: Cumberland Valley Retina Consultants, PC
state: Maryland
city: Coon Rapids
country: United States
facility: Twin Cities Eye Consultants
state: Minnesota
city: Reno
country: United States
facility: Sierra Eye Associates
state: Nevada
city: Eugene
country: United States
facility: Verum Research, LLC
state: Oregon
city: Erie
country: United States
facility: Erie Retina Research
state: Pennsylvania
city: Philadelphia
country: United States
facility: MidAtlantic Retina Research
state: Pennsylvania
city: Greenville
country: United States
facility: Retina Consultants of Carolina
state: South Carolina
city: Mount Pleasant
country: United States
facility: Carolina Eyecare Physicians LLC
state: South Carolina
city: Abilene
country: United States
facility: Retina Research Institute of Texas
state: Texas
city: Arlington
country: United States
facility: Texas Retina Associates
state: Texas
city: Austin
country: United States
facility: Austin Research Center for Retina
state: Texas
city: Austin
country: United States
facility: Austin Clinical Research, LLC
state: Texas
city: Dallas
country: United States
facility: Texas Retina Associates
state: Texas
city: San Antonio
country: United States
facility: Retina Consultants of Texas - San Antonio
state: Texas
city: Arecibo
country: Puerto Rico
facility: Emanuelli Research and Development Center, LLC
Study officials:
affiliation: Aerie Pharmaceuticals
name: Director of Clinical Development, Alcon
role: STUDY_DIRECTOR
References: