Phase 4 Study: Long-term Safety and Efficacy of NT-501 in MacTel Type 2, Including Sham Procedure Participants
Public ClinicalTrials.gov record NCT06971939. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 and have retained at least 1 NT-501 at study entry. 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.
Study identification
- NCT ID
- NCT06971939
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 234 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 20, 2025
- Primary completion
- Jan 14, 2032
- Completion
- Jan 14, 2032
- Last update posted
- Aug 12, 2026
2025 – 2032
United States locations
- U.S. sites
- 23
- U.S. states
- 16
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Scripps Health | La Jolla | California | 92037 | Not yet recruiting |
| Jules Stein Eye Institute/UCLA | Los Angeles | California | 90085 | Not yet recruiting |
| Stanford University School of Medicine | Palo Alto | California | 94303 | Not yet recruiting |
| Bay Area Retina Associates | Walnut Creek | California | 94598 | Recruiting |
| Colorado Retina | Lakewood | Colorado | 80228 | Not yet recruiting |
| Bascom Palmer | Miami | Florida | 33136 | Not yet recruiting |
| Emory Eye Center | Atlanta | Georgia | 30322 | Recruiting |
| Northwestern University | Chicago | Illinois | 60611 | Recruiting |
| National Eye Institute | Bethesda | Maryland | 20892 | Not yet recruiting |
| Cumberland Valley Retina Consultants | Frederick | Maryland | 21702 | Not yet recruiting |
| Massachusetts Eye and Ear Infirmary, Retina Service | Boston | Massachusetts | 02114 | Not yet recruiting |
| Foundation for Vision Research | Grand Rapids | Michigan | 49525 | Recruiting |
| Retina Consultants of Minnesota | Minneapolis | Minnesota | 55435 | Not yet recruiting |
| Envision Ocular, LLC | Bloomfield | New Jersey | 07003 | Not yet recruiting |
| Cincinnati Eye Institute | Cincinnati | Ohio | 45242 | Recruiting |
| Retina Associates of Cleveland, Inc. | Cleveland | Ohio | 44126 | Recruiting |
| Retina Northwest, P.C. | Portland | Oregon | 97221 | Not yet recruiting |
| Scheie Eye Institute | Philadelphia | Pennsylvania | 19104 | Not yet recruiting |
| Southeastern Retina Associates, P.C. | Knoxville | Tennessee | 37922 | Recruiting |
| Texas Retina Associates | Dallas | Texas | 75231 | Recruiting |
| Retina Center of Texas | Dallas | Texas | 75251 | Recruiting |
| Retina Consultants of Texas | Houston | Texas | 77030 | Recruiting |
| University of Utah John A. Moran Center | Salt Lake City | Utah | 84132 | Not yet recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06971939, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 12, 2026 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06971939 live on ClinicalTrials.gov.