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RECRUITING
NCT06971939
PHASE4

Phase 4 Study: Long-term Safety and Efficacy of NT-501 in MacTel Type 2, Including Sham Procedure Participants

Sponsor: Neurotech Pharmaceuticals

View on ClinicalTrials.gov

Summary

The purpose of this global, multicenter, open-label, Phase 4 clinical extension study is to evaluate the long-term safety and efficacy of revakinagene taroretcel-lwey (Encelto™; hereinafter referred to as NT-501), in participants with macular telangiectasia type 2 (MacTel) who previously received the intraocular implant in a Phase 1, Phase 2, or Phase 3 clinical study. In addition, this study will evaluate the safety and efficacy of NT501 in participants who previously underwent the sham procedure in a Phase 3 MacTel clinical study and elect to have NT-501 implanted intraocularly in this Phase 4 study.

Official title: A Phase 4, Multicenter, Open-label Study to Evaluate Long-term Safety and Efficacy of Revakinagene Taroretcel-Lwey (NT-501) Previously Implanted During a Phase 1, Phase 2, or Phase 3 Clinical Study and to Evaluate NT-501 Implanted in Participants Who Underwent the Sham Procedure in a Phase 3 Clinical Study of Macular Telangiectasia Type 2 (MacTel)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

285

Start Date

2025-11-21

Completion Date

2032-01-15

Last Updated

2026-04-03

Healthy Volunteers

No

Interventions

COMBINATION_PRODUCT

NT-501/revakinagene taroretcel-lwey

NT-501 is surgically implanted into the vitreous cavity to continuously release recombinant human ciliary neurotrophic factor (CNTF).

Locations (34)

Scripps Health

La Jolla, California, United States

Jules Stein Eye Institute/UCLA

Los Angeles, California, United States

Stanford University School of Medicine

Palo Alto, California, United States

Bay Area Retina Associates

Walnut Creek, California, United States

Colorado Retina

Lakewood, Colorado, United States

Bascom Palmer

Miami, Florida, United States

Emory Eye Center

Atlanta, Georgia, United States

Northwestern University

Chicago, Illinois, United States

Elman Retina Group, PA

Baltimore, Maryland, United States

National Eye Institute

Bethesda, Maryland, United States

Cumberland Valley Retina Consultants

Frederick, Maryland, United States

Massachusetts Eye and Ear Infirmary, Retina Service

Boston, Massachusetts, United States

Foundation for Vision Research

Grand Rapids, Michigan, United States

Retina Consultants of Minnesota

Minneapolis, Minnesota, United States

Envision Ocular, LLC

Bloomfield, New Jersey, United States

Cincinnati Eye Institute

Cincinnati, Ohio, United States

Retina Associates of Cleveland, Inc.

Cleveland, Ohio, United States

Tulsa Retina Consultants

Tulsa, Oklahoma, United States

Retina Northwest, P.C.

Portland, Oregon, United States

Scheie Eye Institute

Philadelphia, Pennsylvania, United States

Southeastern Retina Associates, P.C.

Knoxville, Tennessee, United States

Texas Retina Associates

Dallas, Texas, United States

Retina Center of Texas

Dallas, Texas, United States

Retina Consultants of Texas

Houston, Texas, United States

University of Utah John A. Moran Center

Salt Lake City, Utah, United States

Cerulea

East Melbourne, Australia

Lion's Eye Institute

Perth, Australia

Sydney Eye Hospital

Sydney, Australia

Lariboisiére Hospital

Paris, France

University Eye Hospital Bonn

Bonn, Germany

UNIVERSITÄTSKLINIKUM FREIBURG, Klinik für Augenheilkunde

Freiburg im Breisgau, Germany

Augenzentrum am St. Franziskus-Hospital

Münster, Germany

Moorefield Hospital

London, United Kingdom

Oxford University Hospitals NHS FT

Oxford, United Kingdom