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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01327911

Enrollment

Registered

2011-04-04

Start date

2011-05-31

Completion date

2016-09-30

Last updated

2016-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Juxtafoveal Telangiectasia

Keywords

Mactel, Macular Telangiectasia Type 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.

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)

Interventions

BIOLOGICALNT-501 implant

Ciliary neurotrophic factor (CNTF) implant

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

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;

Design outcomes

Primary

Measure	Time frame	Description
Visual Acuity	3,12, 24 and 36 months	Visual acuity decrease of \>=15 letters

Secondary

Measure	Time frame	Description
Microperimetry	12, 24 and 36 months	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
OCT	12, 24, and 36 months	Change in en face area as measured by OCT

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026