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

Sponsor
Neurotech Pharmaceuticals (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03319849
Collaborator
(none)
113
Enrollment
27
Locations
2
Arms
54.8
Anticipated Duration (Months)
4.2
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 :
113 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 :
Feb 6, 2018
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 Internal 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 Retina-Vitreous Associates Medical Group Beverly Hills California United States 90211
2 Retina Consultants of Southern Colorado, P.C. Colorado Springs Colorado United States 80909
3 Emory University Eye Center Atlanta Georgia United States 30322
4 Northwestern University, Department of Ophthalmology Chicago Illinois United States 60611
5 Elman Retina Group, PA Baltimore Maryland United States 21237
6 Massachusetts Eye and Ear Infirmary Boston Massachusetts United States 02114
7 New England Retina Consultants Springfield Massachusetts United States 01107
8 University of Michigan, Kellogg Eye Center Ann Arbor Michigan United States 48105
9 Mayo Clinic Rochester Minnesota United States 55905
10 The Retina Institute Chesterfield Missouri United States 63017
11 University of Rochester Strong Memorial Hospital Rochester New York United States 14642
12 Cincinnati Eye Institute Cincinnati Ohio United States 45242
13 Retina Associates of Cleveland, Inc Cleveland Ohio United States 44122
14 Tulsa Retina Consultants Tulsa Oklahoma United States 74114
15 Retina Northwest, P.C. - Sylvan Portland Oregon United States 97210
16 University of Pennsylvania, Department of Ophthalmology, Scheie Eye Institute Philadelphia Pennsylvania United States 19104
17 Palmetto Retina Center West Columbia South Carolina United States 29169
18 Southeastern Retina Associates, PC Knoxville Tennessee United States 37922
19 Retina Research Institute of Texas Abilene Texas United States 79606
20 Retina Research Center, PLLC Austin Texas United States 78705
21 Retina Center of Texas Grapevine Texas United States 76051
22 Retina Consultants of Houston, PA Houston Texas United States 77030
23 Sydney Eye Hospital Sydney New South Wales Australia 2000
24 Royal Victorian Eye and Ear Hospital Research and Ethics Committee East Melbourne Victoria Australia 3002
25 Universitäts Klinikum Bonn Bonn Germany 53127
26 Klinik für Augenheilkunde, Universitätsklinikum Freiburg Augenklinik Retinologie Studien Freiburg Germany 79106
27 St. Franziskus Hospital Münster Germany 48145

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:
NCT03319849
Other Study ID Numbers:
  • NTMT-03-B
First Posted:
Oct 24, 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