Actively Recruiting
Phase 4 Study Evaluating Long-term Safety and Efficacy of NT-501 Implant in Macular Telangiectasia Type 2 Participants Previously Treated or Sham-Treated in Earlier Trials
Led by Neurotech Pharmaceuticals · Updated on 2026-06-01
285
Participants Needed
26
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the long-term safety and effectiveness of revakinagene taroretcel-lwey (NT-501), an intraocular implant, in adults with macular telangiectasia type 2 (MacTel) who previously participated in Phase 1, 2, or 3 clinical studies. This Phase 4, global, multicenter, open-label extension study also includes participants who previously had a sham procedure and now elect to receive the NT-501 implant in this trial. The study has three groups: Arm 1 follows participants who received NT-501 in a Phase 3 study, Arm 2 follows those implanted in Phase 1 or 2 studies, and Arm 3 includes participants who had the sham procedure and will now receive the NT-501 implant. Arms 1 and 2 are observational with no new treatment given, while Arm 3 involves surgical implantation of NT-501 in eligible eyes. The implant releases a neurotrophic factor continuously to potentially support retinal health. Participants will have regular assessments including eye exams and imaging to monitor safety and vision changes. Researchers will track adverse events and measure vision loss, retinal sensitivity, reading speed, and quality of life using questionnaires at baseline, perioperative points, and annually for up to five years. The study aims to provide detailed data on long-term outcomes and safety for participants with MacTel receiving or previously receiving NT-501.
CONDITIONS
Brief 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...
- Adults who previously completed an NT-501 MacTel clinical study
- For Arm 1: received NT-501 implant in a Phase 3 study
- For Arm 2: received NT-501 implant in Phase 1, Phase 2, or Phase 1/2 extension studies
- Participants who received NT-501 in both eyes enrolled based on first implant study
- For Arm 3: underwent sham procedure in a Phase 3 study and elect to receive NT-501 implant
- Must have stable eye fixation and clear media for good quality retinal imaging
- Able to provide written informed consent according to regulations
- For Arm 3 females of childbearing potential: agree to use highly effective contraception
You will not qualify if you...
- Unable to comply with study procedures or visits
- Any physical or mental condition increasing risk or interfering with study
- For Arm 3 only: significant corneal or media opacities in study eye
- Pathologic myopia in study eye to be implanted
- Specific lens opacities exceeding defined standards in study eye
- Recent lens removal or YAG laser in study eye
- Other ocular diseases in study eye that may affect study outcomes
- Intravitreal steroid therapy in study eye within last year
- Intravitreal anti-VEGF therapy in study eye within last 6 months
- Active exudative or neovascular eye conditions in study eye
- Central serous chorioretinopathy in study eye
- Prior eye surgeries like vitrectomy or keratoplasty in study eye
- History of ocular herpes virus in study eye
- Currently undergoing chemotherapy
- Pregnant or breastfeeding
- Participation in another clinical study within 6 months
- History of malignancy affecting survival during study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Perioperative period
Participants in Arm 3 undergo NT-501 implant surgery followed by immediate post-operative care.
1 surgical visit and perioperative visits
Duration - Up to 5 years
Participants in Arms 1 and 2 are observed long-term without new treatment, while Arm 3 participants are monitored after implantation for safety and efficacy.
Annual visits for up to 5 years
Trial Site Locations
Total: 26 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
Retina Northwest, P.C.
Portland, Oregon, United States, 97221
Not Yet Recruiting
18
Scheie Eye Institute
Philadelphia, Pennsylvania, United States, 19104
Not Yet Recruiting
19
Southeastern Retina Associates, P.C.
Knoxville, Tennessee, United States, 37922
Actively Recruiting
20
Texas Retina Associates
Dallas, Texas, United States, 75231
Actively Recruiting
21
Retina Center of Texas
Dallas, Texas, United States, 75251
Actively Recruiting
22
Retina Consultants of Texas
Houston, Texas, United States, 77030
Actively Recruiting
23
University of Utah John A. Moran Center
Salt Lake City, Utah, United States, 84132
Actively Recruiting
24
Cerulea
East Melbourne, Australia
Actively Recruiting
25
Lion's Eye Institute
Perth, Australia
Actively Recruiting
26
Sydney Eye Hospital
Sydney, Australia
Actively Recruiting
Research Team
P
Patricia Davis
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here