Actively Recruiting
Phase 4 Study: Long-term Safety and Efficacy of NT-501 in MacTel Type 2, Including Sham Procedure Participants
Led by Neurotech Pharmaceuticals · Updated on 2026-04-29
285
Participants Needed
33
Research Sites
320 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase 4 Study: Long-term Safety and Efficacy of NT-501 in MacTel Type 2, Including Sham Procedure Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female adults who previously completed an NT-501 MacTel clinical study
- Participants who received NT-501 implant in Phase 3 studies (Arm 1)
- Participants who received NT-501 implant in Phase 1 or Phase 2 studies (Arm 2)
- Participants who previously underwent the sham procedure in Phase 3 studies and choose to receive NT-501 implant (Arm 3)
- Participants must have steady fixation in the foveal or parafoveal area and clear media for quality retinal imaging
- Participants or their legally authorized representatives must provide written informed consent
- Female participants of childbearing potential in Arm 3 must agree to use highly effective contraception during the study, with specific contraception requirements in France or Germany
You will not qualify if you...
- Unable to comply with study procedures or visits
- Physical or mental conditions that increase risk or interfere with study assessments
- Significant corneal or media opacities in the study eye to be implanted (Arm 3 only)
- Evidence of pathologic myopia in the study eye (Arm 3 only)
- Certain lens opacities exceeding specified grades in the study eye (Arm 3 only)
- Lens removal within 3 months or YAG laser within 4 weeks before baseline in study eye (Arm 3 only)
- Ocular diseases other than MacTel that may affect study outcomes (Arm 3 only)
- Intravitreal steroid therapy within 1 year in study eye (Arm 3 only)
- Intravitreal anti-VEGF therapy within 6 months in study eye (Arm 3 only)
- Active exudative intraretinal or subretinal neovascularization in study eye (Arm 3 only)
- Central serous chorioretinopathy in study eye (Arm 3 only)
- Prior vitrectomy, penetrating keratoplasty, trabeculectomy, or trabeculoplasty in study eye (Arm 3 only)
- History of ocular herpes virus in study eye (Arm 3 only)
- Currently on chemotherapy
- Pregnant or breastfeeding
- Participation in any other clinical study of an intervention within 6 months before baseline
- History of malignancy compromising survival during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 33 locations
1
Scripps Health
La Jolla, California, United States, 92037
Not Yet Recruiting
2
Jules Stein Eye Institute/UCLA
Los Angeles, California, United States, 90085
Not Yet Recruiting
3
Stanford University School of Medicine
Palo Alto, California, United States, 94303
Not Yet Recruiting
4
Bay Area Retina Associates
Walnut Creek, California, United States, 94598
Actively Recruiting
5
Colorado Retina
Lakewood, Colorado, United States, 80228
Actively Recruiting
6
Bascom Palmer
Miami, Florida, United States, 33136
Not Yet Recruiting
7
Emory Eye Center
Atlanta, Georgia, United States, 30322
Actively Recruiting
8
Northwestern University
Chicago, Illinois, United States, 60611
Not Yet Recruiting
9
National Eye Institute
Bethesda, Maryland, United States, 20892
Not Yet Recruiting
10
Cumberland Valley Retina Consultants
Frederick, Maryland, United States, 21702
Not Yet Recruiting
11
Massachusetts Eye and Ear Infirmary, Retina Service
Boston, Massachusetts, United States, 02114
Not Yet Recruiting
12
Foundation for Vision Research
Grand Rapids, Michigan, United States, 49525
Actively Recruiting
13
Retina Consultants of Minnesota
Minneapolis, Minnesota, United States, 55435
Not Yet Recruiting
14
Envision Ocular, LLC
Bloomfield, New Jersey, United States, 07003
Actively Recruiting
15
Cincinnati Eye Institute
Cincinnati, Ohio, United States, 45242
Actively Recruiting
16
Retina Associates of Cleveland, Inc.
Cleveland, Ohio, United States, 44126
Actively Recruiting
17
Tulsa Retina Consultants
Tulsa, Oklahoma, United States, 74132
Not Yet Recruiting
18
Retina Northwest, P.C.
Portland, Oregon, United States, 97221
Not Yet Recruiting
19
Scheie Eye Institute
Philadelphia, Pennsylvania, United States, 19104
Not Yet Recruiting
20
Southeastern Retina Associates, P.C.
Knoxville, Tennessee, United States, 37922
Actively Recruiting
21
Texas Retina Associates
Dallas, Texas, United States, 75231
Not Yet Recruiting
22
Retina Center of Texas
Dallas, Texas, United States, 75251
Actively Recruiting
23
Retina Consultants of Texas
Houston, Texas, United States, 77030
Actively Recruiting
24
University of Utah John A. Moran Center
Salt Lake City, Utah, United States, 84132
Actively Recruiting
25
Cerulea
East Melbourne, Australia
Actively Recruiting
26
Lion's Eye Institute
Perth, Australia
Actively Recruiting
27
Sydney Eye Hospital
Sydney, Australia
Actively Recruiting
28
Lariboisiére Hospital
Paris, France
Not Yet Recruiting
29
University Eye Hospital Bonn
Bonn, Germany
Not Yet Recruiting
30
UNIVERSITÄTSKLINIKUM FREIBURG, Klinik für Augenheilkunde
Freiburg im Breisgau, Germany
Not Yet Recruiting
31
Augenzentrum am St. Franziskus-Hospital
Münster, Germany
Not Yet Recruiting
32
Moorefield Hospital
London, United Kingdom
Not Yet Recruiting
33
Oxford University Hospitals NHS FT
Oxford, United Kingdom
Not Yet Recruiting
Research Team
P
Patricia Davis
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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