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

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: NCT03316300
• Other study ID #: NTMT-03-A
• Status: Completed
• Phase: Phase 3
• Start date: November 24, 2017
• Est. completion date: September 23, 2022

Study information

• Verified date: October 2022
• 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: 115
• 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	Lions Eye Institute	Perth	Western Australia
France	Cochin Hospital	Paris
United Kingdom	Moorfields Eye Hospital	London
United Kingdom	Oxford Eye Hospital, Oxford University Hospitals NHS Foundation Trust	Oxford	Oxfordshire
United States	National Institute of Health	Bethesda	Maryland
United States	Retina Associates of Cleveland, Inc.	Cleveland	Ohio
United States	Retina Consultants of Southern Colorado, P.C.	Colorado Springs	Colorado
United States	Texas Retina Associates	Dallas	Texas
United States	Charles Retina Institute	Germantown	Tennessee
United States	Cumberland Valley Retina Consultants	Hagerstown	Maryland
United States	Southeastern Retina Associates, PC	Knoxville	Tennessee
United States	Scripps Clinic Carmel Valley Ambulatory Surgery Center	La Jolla	California
United States	Global Research Foundation	Los Angeles	California
United States	Jules Stein Eye Institute / David Geffen School of Medicine	Los Angeles	California
United States	Retina Associates of New Orleans	Metairie	Louisiana
United States	Byers Eye Institute at Stanford	Palo Alto	California
United States	Sierra Eye Associates	Reno	Nevada
United States	Associated Retinal Consultants, P.C.	Royal Oak	Michigan
United States	University of Utah John A. Moran Eye Center	Salt Lake City	Utah
United States	Tulsa Retina Consultants	Tulsa	Oklahoma
United States	Bay Area Retina Associates	Walnut Creek	California
United States	Center for Retina and Macular Disease	Winter Haven	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Neurotech Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  France,  United Kingdom, 

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 International 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.