Summary

Eligibility
for people ages 21-80 (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

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.

Official Title

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

Keywords

Macular Telangiectasia Type 2 Ciliary Neurotrophic Factor (CNTF) Macular Telangiectasia (MacTel) Telangiectasis

Eligibility

You can join if…

Open to people ages 21-80

  • 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 mm2 and 2.00 mm2

  • 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

You CAN'T join if...

  • 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

Locations

  • Jules Stein Eye Institute / David Geffen School of Medicine
    Los Angeles California 90095 United States
  • Scripps Clinic Carmel Valley Ambulatory Surgery Center
    La Jolla California 92037 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Neurotech Pharmaceuticals
ID
NCT03316300
Phase
Phase 3
Study Type
Interventional
Last Updated