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A Study to Determine the Safety and Efficacy of NT-501 in Macular Telangiectasia Type 2 - Protocol A

Sponsor
Neurotech Pharmaceuticals (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03316300
Collaborator
(none)
115
Enrollment
22
Locations
2
Arms
57.2
Anticipated Duration (Months)
5.2
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Combination Product: NT-501
  • Procedure: Sham
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
115 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase III Multicenter Randomized, Sham Controlled, Study to Determine the Safety and Efficacy of NT-501 in Macular Telangiectasia Type 2
Actual Study Start Date :
Nov 24, 2017
Anticipated Primary Completion Date :
Aug 31, 2022
Anticipated Study Completion Date :
Aug 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: NT-501

Combination Product: NT-501
Surgery to receive one NT-501 device implant.
Sham Comparator: Sham

Procedure: Sham
Non-penetrating sham procedure to mimic implant procedure.

Outcome Measures

Primary Outcome Measures

  1. Rate of Change in Ellipsoid Zone (EZ) Area Loss [Baseline through 24 months.]

    Rate of change in EZ area loss as measured by en face imaging by Spectral-Domain Optical Coherence Tomography (SD-OCT) in the study eye.

Secondary Outcome Measures

  1. Mean Change in Aggregate Sensitivity of Microperimetry [Baseline through 24 months.]

    NT-501 compared to sham relative to mean change in aggregate sensitivity of microperimetry within the EZ line break area.

  2. Mean Change in Reading Speed [Baseline through 24 months.]

    NT-501 compared to sham relative to mean change in reading speed assessed using International Reading Speed Texts (IReST) cards.

  3. National Eye Institute-Visual Function Questionnaire (NEI-VFQ) [Baseline through 24 months.]

    NT-501 compared to sham relative to mean change in the NEI-VFQ near activities subscale score.

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 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

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Scripps Clinic Carmel Valley Ambulatory Surgery Center La Jolla California United States 92037
2 Global Research Foundation Los Angeles California United States 90041
3 Jules Stein Eye Institute / David Geffen School of Medicine Los Angeles California United States 90095
4 Byers Eye Institute at Stanford Palo Alto California United States 94303
5 Bay Area Retina Associates Walnut Creek California United States 94598
6 Retina Consultants of Southern Colorado, P.C. Colorado Springs Colorado United States 80909
7 Center for Retina and Macular Disease Winter Haven Florida United States 33880
8 Retina Associates of New Orleans Metairie Louisiana United States 70006
9 National Institute of Health Bethesda Maryland United States 20892
10 Cumberland Valley Retina Consultants Hagerstown Maryland United States 21740
11 Associated Retinal Consultants, P.C. Royal Oak Michigan United States 48073
12 Sierra Eye Associates Reno Nevada United States 89502
13 Retina Associates of Cleveland, Inc. Cleveland Ohio United States 44122
14 Tulsa Retina Consultants Tulsa Oklahoma United States 74114
15 Charles Retina Institute Germantown Tennessee United States 38138
16 Southeastern Retina Associates, PC Knoxville Tennessee United States 37909
17 Texas Retina Associates Dallas Texas United States 75231
18 University of Utah John A. Moran Eye Center Salt Lake City Utah United States 84132
19 Lions Eye Institute Perth Western Australia Australia 6009
20 Cochin Hospital Paris France 75010
21 Oxford Eye Hospital, Oxford University Hospitals NHS Foundation Trust Oxford Oxfordshire United Kingdom OX3 9DU
22 Moorfields Eye Hospital London United Kingdom EC1V 2PD

Sponsors and Collaborators

  • Neurotech Pharmaceuticals

Investigators

  • Principal Investigator: Emily Chew, MD, National Eye Institute (NEI)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Neurotech Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT03316300
Other Study ID Numbers:
  • NTMT-03-A
First Posted:
Oct 20, 2017
Last Update Posted:
Mar 17, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
Yes
Keywords provided by Neurotech Pharmaceuticals
Ciliary Neurotrophic Factor (CNTF)
Macular Telangiectasia (MacTel)
Additional relevant MeSH terms:
Telangiectasis

Study Results

No Results Posted as of Mar 17, 2022