A Phase 2 Multicenter Randomized Clinical Trial of CNTF for MacTel

Phase 2CompletedNCT01949324

Neurotech Pharmaceuticals67 enrolled

Overview

This study is a phase 2, randomized, multi-center, single-masked study to evaluate the efficacy and safety of the NT-501 implants in participants with Mactel.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Macular Telangiectasia Type 2

Interventions

Ciliary neurotrophic factor (CNTF)BIOLOGICAL

Ciliary neurotrophic factor released from NT-501 encapsulated cell implant

Sham procedurePROCEDURE

Sham surgery for Sham arm

NT-501 ImplantDEVICE

NT-501 encapsulated cell implant

Eligibility

Sex: ALLMin age: 21 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participant must be offered sufficient opportunity to review and to understand the informed consent form, agree to the form's contents and sign the protocol's informed consent * Participant must have at least one study eye with a positive diagnosis of MacTel Type 2 * Participant must have an IS/OS PR break in the study eye(s) and en face ellipsoid zone (area of IS/OS loss) as measured by SDOCT between 0.16 mm2 and 4.00 mm2 * If female, participant must be incapable of pregnancy * If male, participant must agree to use an effective form of birth control during the study Exclusion Criteria: * Participant is unable to provide informed consent * Participant is less than 21 years of age or greater than 80 years of age * Participant is medically unable to comply with study procedures or follow-up visits * Participant was a study subject in any other clinical trial of an intervention (drug or device) within the last 6 months * Participant is pregnant or breastfeeding

Locations (11)

Jules Stein Eye Institute

Los Angeles, California, United States

Bascom Palmer

Miami, Florida, United States

Emory University

Atlanta, Georgia, United States

Outcomes

Primary Outcomes

Ellipsoid zone (area of IS/OS loss) as measured by en face imagining by SDOCT in study eye(s)

Change in the ellipsoid zone (area of IS/OS loss) from baseline to month 24 as measured by en face imaging by SDOCT in study eye(s)

Time frame: 24 months

Secondary Outcomes

Ellipsoid zone

Change in the ellipsoid zone from baseline to Month 12.

Time frame: 12 months

Retinal sensitivity (dB) as measured by microperimetry

Change in retinal sensitivity (dB) as measured by microperimetry from baseline to Months 12 and 24.

Time frame: 12 and 24 months

Increase in ellipsoid zone

Proportion of study eyes with a 35% or more increase from baseline in the ellipsoid zone at Months 12 and 24.

Time frame: 12 and 24 months

Visual Acuity

Change in best corrected visual acuity (BCVA) from baseline to Months 12 and 24.

Time frame: 12 and 24 months

Visual Acuity

Proportion of study eyes with 15 or more letter loss from baseline in BCVA at Months 12 and 24.

Time frame: 12 and 24 Months

Visual Acuity

Proportion of study eyes with 10 or more letter loss from baseline in BCVA at Months 12 and 24.

Time frame: 12 and 24 Months

Reading Speed

Change in reading speed as measured by the IReST from baseline to Months 12 and 24.

Data from ClinicalTrials.gov

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