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

NTMT-03-A

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.

2017-11-24

2022-08-31

2022-09-23

Completed

Early phase I

115

Key Inclusion Criteria: * Participant must have at least one study eye with a positive diagnosis of MacTel Type 2 * Participant must have an Inner Segment - Outer Segment Junction Line (IS/OS) Photo Receptor (PR) break in the study eye(s) and en face EZ (area of IS/OS loss) as measured by spectral-domain optical coherence tomography (SDOCT) between 0.16 mm\^2 and 2.00 mm\^2 * Participant's best corrected visual acuity is 54 letter score or better (20/80 or better) as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) chart Key Exclusion Criteria: * Participant received intravitreal steroid therapy for non-neovascular MacTel within the last 3 months * Participant has ever received intravitreal anti-vascular endothelial growth factor (VEGF) therapy in the study eye or has, within the past 3 months, received intravitreal anti-VEGF in the fellow eye * Participant has evidence of ocular disease other than MacTel that, in the judgment of the examining physician, may confound the diagnosis, procedures or outcome of the study * Participant was a study participant in any other clinical trial of an intervention (drug or device) within the last 6 months * Participant is pregnant or breastfeeding * Participant has a chronic requirement (eg ≥ 4 weeks at a time) for ocular medications

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2023-02-08