Ciliary Neurotrophic Factor (CNTF) Safety Trial in Patients With Macular Telangiectasia (Mactel)

NCT01327911 | Completed Phase 1 DMC

• 1 other identifier: NTMT-01
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 2

Brief Summary

This study is a phase 1, open label, non-randomized, multi-center, pilot study to evaluate the safety and tolerability of NT-501 implants in 5-7 study participants with Mactel.

Conditions

Idiopathic Juxtafoveal Telangiectasia

Keywords

Mactel; Macular Telangiectasia Type 2

Outcome Measures

Primary Outcomes (1)

• Visual Acuity

  Visual acuity decrease of \>=15 letters

  3,12, 24 and 36 months

Secondary Outcomes (2)

• Microperimetry

  12, 24 and 36 months

• OCT

  12, 24, and 36 months

Study Arms (1)

Ciliary Neurotrophic Factor (CNTF)/NT-501

EXPERIMENTAL

Biological/Vaccine:NT-501 implant

Biological: NT-501 implant

Interventions

NT-501 implant BIOLOGICAL

Ciliary neurotrophic factor (CNTF) implant

Ciliary Neurotrophic Factor (CNTF)/NT-501

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The participant must be offered sufficient opportunity to review the informed consent form, agree to the form's contents and sign the protocol's informed consent;
• The participant must have bilateral MacTel;
• Women of childbearing potential and all men must agree to use an effective form of birth control during the study;
• Participant must be medically able to undergo ophthalmic surgery for ECT implant;
• The participant's best-corrected visual acuity 64 letters or better (20/50 or better) in the study eye;

You may not qualify if:

• Participant is \< 21 years of age;
• Participant is medically unable to comply with study procedures or follow- up visits;
• Participant has evidence of ocular disease other than MacTel that may confound the outcome of the study (e.g., diabetic retinopathy with manifest macular edema, uveitis, etc.);
• Participant has a chronic requirement (e.g., ≥ 4 weeks at a time) for ocular medications and/or has a diagnosed disease, that in the judgment of the examining physician, may be vision threatening or may affect the primary outcome (artificial tears are permitted);
• Participant has evidence of subretinal neovascularization in either eye;
• Participant has evidence of central serous chorio-retinopathy (CSR) in either eye;
• Participant has evidence of pathologic myopia in either eye;
• Participant has had a vitrectomy, penetrating keratoplasty, trabeculectomy or trabeculoplasty;

Sponsors & Collaborators

• Neurotech Pharmaceuticals: lead
• The Lowy Medical Research Institute Limited: collaborator

Study Sites (2)

Jules Stein Eye Institute

Los Angeles, California, 90095, United States

Location

Retina Associates of Cleveland

Cleveland, Ohio, 44122, United States

Location

MeSH Terms

Conditions

Idiopathic Juxtafoveal Retinal Telangiectasia

Study Officials

• Weng Tao

  Neurotech USA

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2011
• First Posted: April 4, 2011
• Study Start: May 1, 2011
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: November 22, 2016

Record last verified: 2016-11

Locations

US (2)