CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 120 enrolled
Drug / intervention
NT-501 +1 morecombination
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03316300
NCT03316300Phase 3Completed
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A Phase III Multicenter Randomized, Sham Controlled, Study to Determine the Safety and Efficacy of NT-501 in Macular Telangiectasia Type 2

Neurotech Pharmaceuticals·interventional·Posted Oct 20, 2017·Updated Sep 24, 2024

In Brief

A Phase 3 clinical trial evaluating NT-501 and Sham Procedure for Macular Telangiectasia Type 2 (MacTel). Completed, enrolled 120 participants across 20 sites in 4 countries.

Detailed Summary

This study is a phase 3, randomized, multi-center study to evaluate the efficacy and safety of the NT-501 implants in participants with macular telangiectasia type 2.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMacular Telangiectasia Type 2 (MacTel)
CountriesAustralia, France, United Kingdom, United States
CollaboratorsThe Lowy Medical Research Institute Limited

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedOct 20, 2017
Enrollment StartNov 24, 2017
Primary CompletionAug 31, 2022
Study CompletionSep 23, 2022
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 8.7 years ago

Interventions

NT-501combination

Each NT-501 implant consisted of hCNTF-secreting NTC-201-6A.02 cells encapsulated within supportive matrices and surrounded by a semipermeable polymer membrane. The NTC-201-6A cells continuously secrete CNTF from the NT-501 implant into the vitreous cavity. Implanted by a qualified Health Care Professional.

Sham Procedureprocedure

The sham surgery involved a superficial conjunctival incision performed under local anesthetic and closure with a single suture.