Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| The Lowy Medical Research Institute Limited | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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)
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ciliary Neurotrophic Factor (CNTF)/NT-501 | Experimental | Biological/Vaccine:NT-501 implant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NT-501 implant | Biological | Ciliary neurotrophic factor (CNTF) implant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity | Visual acuity decrease of >=15 letters | 3,12, 24 and 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| OCT |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Weng Tao | Neurotech USA | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jules Stein Eye Institute | Los Angeles | California | 90095 | United States | ||
| Retina Associates of Cleveland |
Not provided
| ID | Term |
|---|---|
| C548027 | Idiopathic Juxtafoveal Retinal Telangiectasia |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Change in en face area as measured by OCT
| 12, 24, and 36 months |
| Cleveland |
| Ohio |
| 44122 |
| United States |