RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

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

Quick Facts

Study Start:2023-12-06
Study Completion:2027-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05769153

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Alcon Call Center
CONTACT
1-888-451-3937
alcon.medinfo@alcon.com

Principal Investigator

Director of Clinical Development, Alcon
STUDY_DIRECTOR
Aerie Pharmaceuticals

Study Locations (Sites)

Northern California Retina Vitreous Associates Medical Group
Mountain View, California, 94040
United States
Retina Specialty Institute
Pensacola, Florida, 32503
United States
Retina Vitreous Associates of Florida
Saint Petersburg, Florida, 33711
United States
MidAtlantic Retina Research
Philadelphia, Pennsylvania, 19107
United States
Retina Research Institute of Texas
Abilene, Texas, 79606
United States
Medical Center Ophthalmology Associates
San Antonio, Texas, 78240
United States

Collaborators and Investigators

Sponsor: Alcon Research

  • Director of Clinical Development, Alcon, STUDY_DIRECTOR, Aerie Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-06
Study Completion Date2027-03

Study Record Updates

Study Start Date2023-12-06
Study Completion Date2027-03

Terms related to this study

Keywords Provided by Researchers

  • nAMD
  • retina
  • eyes
  • ophthalmology

Additional Relevant MeSH Terms

  • Neovascular Age-related Macular Degeneration (nAMD)