Clinical trial NCT01949324: A Phase 2 Multicenter Randomized Clinical Trial of CNTF for MacTel
Official title: A Phase 2 Multicenter Randomized Clinical Trial of Ciliary Neurotrophic Factor (CNTF) for Macular Telangiectasia Type 2 (MacTel)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Macular Telangiectasia Type 2
Keywords: MacTel
Lead sponsor: Neurotech Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: The Lowy Medical Research Institute Limited
name: The Emmes Company, LLC
First posted: 2013-09-24
Enrollment: 67
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Ellipsoid zone (area of IS/OS loss) as measured by en face imagining by SDOCT in study eye(s)
timeFrame: 24 months
Secondary outcomes:
measure: Ellipsoid zone
timeFrame: 12 months
measure: Retinal sensitivity (dB) as measured by microperimetry
timeFrame: 12 and 24 months
measure: Increase in ellipsoid zone
timeFrame: 12 and 24 months
measure: Visual Acuity
timeFrame: 12 and 24 months
measure: Visual Acuity
timeFrame: 12 and 24 Months
measure: Visual Acuity
timeFrame: 12 and 24 Months
measure: Reading Speed
timeFrame: 12 and 24 Months
Other outcomes:
measure: Cone density as measured by AOSLO
timeFrame: 12 and 24 Months
measure: National Eye Institute Visual Functioning Questionnaire
timeFrame: 12 and 24 months
measure: Electroretinogram changes
timeFrame: 6, 12 and 24 Months
Locations:
city: Los Angeles
country: United States
facility: Jules Stein Eye Institute
state: California
city: Miami
country: United States
facility: Bascom Palmer
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Bethesda
country: United States
facility: National Eye Institute
state: Maryland
city: Boston
country: United States
facility: Massachusetts Eye and Ear Infirmary, Retina Service
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan, Kellogg Eye Center
state: Michigan
city: Beachwood
country: United States
facility: Retina Associates of Cleveland, Inc.
state: Ohio
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
city: Sydney
country: Australia
facility: Save Sight Institute
state: New South Wales
city: East Melbourne
country: Australia
facility: Centre for Eye Research Australia
city: Nedlands
country: Australia
facility: Lions Eye Institute
Study officials:
References:
citation: Loo J, Cai CX, Choong J, Chew EY, Friedlander M, Jaffe GJ, Farsiu S. Deep learning-based classification and segmentation of retinal cavitations on optical coherence tomography images of macular telangiectasia type 2. Br J Ophthalmol. 2022 Mar;106(3):396-402. doi: 10.1136/bjophthalmol-2020-317131. Epub 2020 Nov 23.