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

Macular Telangiectasia Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03319849
• Other study ID #: NTMT-03-B
• Status: Completed
• Phase: Phase 3
• Start date: February 6, 2018
• Est. completion date: September 23, 2022

Study information

• Verified date: February 2023
• Source: Neurotech Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: September 23, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Macular Telangiectasia Type 2
• Telangiectasis

Intervention

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

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

Locations

Country	Name	City	State
Australia	Royal Victorian Eye and Ear Hospital Research and Ethics Committee	East Melbourne	Victoria
Australia	Sydney Eye Hospital	Sydney	New South Wales
Germany	Universitäts Klinikum Bonn	Bonn
Germany	Klinik für Augenheilkunde, Universitätsklinikum Freiburg Augenklinik Retinologie Studien	Freiburg
Germany	St. Franziskus Hospital	Münster
United States	Retina Research Institute of Texas	Abilene	Texas
United States	University of Michigan, Kellogg Eye Center	Ann Arbor	Michigan
United States	Emory University Eye Center	Atlanta	Georgia
United States	Retina Research Center, PLLC	Austin	Texas
United States	Elman Retina Group, PA	Baltimore	Maryland
United States	Retina-Vitreous Associates Medical Group	Beverly Hills	California
United States	Massachusetts Eye and Ear Infirmary	Boston	Massachusetts
United States	The Retina Institute	Chesterfield	Missouri
United States	Northwestern University, Department of Ophthalmology	Chicago	Illinois
United States	Cincinnati Eye Institute	Cincinnati	Ohio
United States	Retina Associates of Cleveland, Inc	Cleveland	Ohio
United States	Retina Consultants of Southern Colorado, P.C.	Colorado Springs	Colorado
United States	Retina Center of Texas	Grapevine	Texas
United States	Retina Consultants of Houston, PA	Houston	Texas
United States	Southeastern Retina Associates, PC	Knoxville	Tennessee
United States	University of Pennsylvania, Department of Ophthalmology, Scheie Eye Institute	Philadelphia	Pennsylvania
United States	Retina Northwest, P.C. - Sylvan	Portland	Oregon
United States	Mayo Clinic	Rochester	Minnesota
United States	University of Rochester Strong Memorial Hospital	Rochester	New York
United States	New England Retina Consultants	Springfield	Massachusetts
United States	Tulsa Retina Consultants	Tulsa	Oklahoma
United States	Palmetto Retina Center	West Columbia	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Neurotech Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Change in Ellipsoid Zone (EZ) Area Loss	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.	Baseline through 24 months.
Secondary	Mean Change in Aggregate Sensitivity of Microperimetry	NT-501 compared to sham relative to mean change in aggregate sensitivity of microperimetry within the EZ line break area.	Baseline through 24 months.
Secondary	Mean Change in Reading Speed	NT-501 compared to sham relative to mean change in reading speed assessed using Internal Reading Speed Texts (IReST) cards.	Baseline through 24 months.
Secondary	National Eye Institute-Visual Function Questionnaire (NEI-VFQ)	NT-501 compared to sham relative to mean change in the NEI-VFQ near activities subscale score.	Baseline through 24 months.