An Efficacy and Safety Study of Cenegermin Ophthalmic Solution Compared With Vehicle in the Treatment of PCED (NCT07519902)
Phase 3, Multicenter, Randomized, Double-Masked, Vehicle-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of Recombinant Human Nerve Growth Factor Eye Drop Solution in Participants With Persistent Corneal Epithelial Defect (PCED)
🩺 Plain-English Summary (8th-Grade Level)
This is a phase 3, randomized, multicenter, double-masked, parallel group, vehicle-controlled prospective clinical trial to evaluate the safety and efficacy of cenegermin in inducing complete epithelial healing in participants with PCED. The primary objective is the evaluation of complete epithelial healing after 4 weeks of treatment. The study is comprised of 3 periods: an 8-week initial treatment period (Day 1 to Week 8), an 8-week extension treatment period (Week 9 to Week 16), and a 24-week follow-up period (Week 17 to Week 40).
Who can join: Review the eligibility criteria below.
Location: Azul Vision, INC — Huntington Beach, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (77 Sites)
Showing the first 25 of 77 sites.
- Azul Vision, INC — Huntington Beach, California
- Harvard Eye Associates — Laguna Hills, California
- Loma Linda University Adventist Health Sciences Center — Loma Linda, California
- UCLA - Jules Stein Eye Institute (JSEI) - Diabetic Eye Dise — Los Angeles, California
- California Eye Specialists Medical Group, Inc. — Redlands, California
- East Coast Institute for Research - Florida Eye Specialists — Jacksonville, Florida
- Bascom Palmer Eye Institute, University of Miami School of Medicine — Miami, Florida
- University of South Florida — Tampa, Florida
- Massachusetts Eye and Ear — Boston, Massachusetts
- Ophthalmic Consultants of Boston — Boston, Massachusetts
- University of Michigan Health - Kellogg Eye Center — Ann Arbor, Michigan
- Midwest Vision Research Foundation — Chesterfield, Missouri
- NYU Langone Eye Center (Ophthalmology) — New York, New York
- Duke Eye Center - Ophthalmology — Durham, North Carolina
- Vance Thompson Vision - Sioux Falls — Sioux Falls, South Dakota
- Houston Eye Associates (HEA) — Houston, Texas
- The Eye Institute of Utah — Salt Lake City, Utah
- Virginia Eye Consultants — Norfolk, Virginia
- Hospital Italiano de Buenos Aires — Ciudad Autonoma de Buenos Aire, Buenos Aires
- Buenos Aires Macula S.A. - Clinic — Ciudad Autónoma de Buenos Aires, Buenos Aires
- Hospital Universitario Austral — Pilar, Buenos Aires
- Fundacion Zambrano — Buenos Aires, Buenos Aires F.D.
- Centro Oftalmologico Dr Charles SA — Buenos Aires, Buenos Aires F.D.
- Oftar S.R.L. — Mendoza,
- FN Brno - Ocni klinika — Brno, Brno-město
📞 Contact the Study Coordinator
Phone: (390) 258-3831
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.