Ciliary Neurotrophic Factor (CNTF) Safety Trial in Patients With Macular Telangiectasia (Mactel)
This study is ongoing, but not recruiting participants.
Sponsor:
Neurotech Pharmaceuticals
Collaborator:
The Lowy Medical Research Institute Limited
Information provided by (Responsible Party):
Neurotech Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01327911
First received: March 30, 2011
Last updated: November 20, 2012
Last verified: November 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Idiopathic Juxtafoveal Telangiectasia |
Biological: NT-501 implant |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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) |
Resource links provided by NLM:
Further study details as provided by Neurotech Pharmaceuticals:
Primary Outcome Measures:
- Visual Acuity [ Time Frame: 3,12 and 24 months ] [ Designated as safety issue: Yes ]Visual acuity decrease of >=15 letters
Secondary Outcome Measures:
- Microperimetry [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]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 [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]Change in en face area as measured by OCT
| Enrollment: | 7 |
| Study Start Date: | May 2011 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Ciliary Neurotrophic Factor (CNTF)/NT-501 |
Biological: NT-501 implant
Ciliary neurotrophic factor (CNTF) implant
|
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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;
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01327911
Locations
| United States, California | |
| Jules Stein Eye Institute | |
| Los Angeles, California, United States, 90095 | |
| United States, Ohio | |
| Retina Associates of Cleveland | |
| Cleveland, Ohio, United States, 44122 | |
Sponsors and Collaborators
Neurotech Pharmaceuticals
The Lowy Medical Research Institute Limited
Investigators
| Study Chair: | Weng Tao | Neurotech USA |
More Information
No publications provided
| Responsible Party: | Neurotech Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01327911 History of Changes |
| Other Study ID Numbers: | NTMT-01 |
| Study First Received: | March 30, 2011 |
| Last Updated: | November 20, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Neurotech Pharmaceuticals:
|
Mactel Macular Telangiectasia Type 2 |
Additional relevant MeSH terms:
|
Telangiectasis Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 19, 2013