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

Idiopathic Juxtafoveal Telangiectasia Clinical Trial

Official title:

A Phase 1 Multicenter Open Label Safety and Tolerability Clinical Trial of Ciliary Neurotrophic Factor (CNTF) in Patients With Macular Telangiectasia Type 2 (Mactel)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01327911
• Other study ID #: NTMT-01
• Status: Completed
• Phase: Phase 1
• First received: March 30, 2011
• Last updated: November 21, 2016
• Start date: May 2011
• Est. completion date: September 2016

Study information

• Verified date: November 2016
• Source: Neurotech Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

Protocol for Extended Follow-up of a Phase 1 Multicenter Open Label Safety and Tolerability Clinical Trial of Ciliary Neurotrophic Factor (CNTF) in Patients with Macular Telangiectasia Type 2 (MacTel)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• 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;

Exclusion Criteria:

• 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;

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Idiopathic Juxtafoveal Telangiectasia
• Telangiectasis

Intervention

Biological:
• NT-501 implant
Ciliary neurotrophic factor (CNTF) implant

Locations

Country	Name	City	State
United States	Retina Associates of Cleveland	Cleveland	Ohio
United States	Jules Stein Eye Institute	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Neurotech Pharmaceuticals	The Lowy Medical Research Institute Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Acuity	Visual acuity decrease of >=15 letters	3,12, 24 and 36 months	Yes
Secondary	Microperimetry	Change of a 10dB at least one point either adjacent to a pre-existing scotoma or in a new area within the central 10 degrees on microperimetric testing	12, 24 and 36 months	No
Secondary	OCT	Change in en face area as measured by OCT	12, 24, and 36 months	No