Clinical trial NCT01327911: Ciliary Neurotrophic Factor (CNTF) Safety Trial in Patients With Macular Telangiectasia (Mactel)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Idiopathic Juxtafoveal Telangiectasia
Keywords: Mactel
Macular Telangiectasia Type 2
Lead sponsor: Neurotech Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: The Lowy Medical Research Institute Limited
First posted: 2011-04-04
Enrollment: 7
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed 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)

Eligibility criteria: 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;

Primary outcomes:
measure: Visual Acuity
timeFrame: 3,12, 24 and 36 months
Secondary outcomes:
measure: Microperimetry
timeFrame: 12, 24 and 36 months
measure: OCT
timeFrame: 12, 24, and 36 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Jules Stein Eye Institute
state: California
city: Cleveland
country: United States
facility: Retina Associates of Cleveland
state: Ohio
Study officials:
affiliation: Neurotech USA
name: Weng Tao
role: STUDY_CHAIR
References: