Macular Telangiectasia Type 2
Conditions
Keywords
MacTel
Brief summary
This study is a phase 2, randomized, multi-center, single-masked study to evaluate the efficacy and safety of the NT-501 implants in participants with Mactel.
Interventions
PROCEDURENT-501 Implant procedure
Surgery to implant device for NT-501 encapsulated cell implant releasing human ciliary neurotrophic factor arm
BIOLOGICALCiliary neurotrophic factor (CNTF)
Ciliary neurotrophic factor released from NT-501 encapsulated cell implant
PROCEDURESham procedure
Sham surgery for Sham arm
DEVICENT-501 Implant
NT-501 encapsulated cell implant
Sponsors
The Lowy Medical Research Institute Limited
The Emmes Company, LLC
Neurotech Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Participant must be offered sufficient opportunity to review and to understand the informed consent form, agree to the form's contents and sign the protocol's informed consent * Participant must have at least one study eye with a positive diagnosis of MacTel Type 2 * Participant must have an IS/OS PR break in the study eye(s) and en face ellipsoid zone (area of IS/OS loss) as measured by SDOCT between 0.16 mm2 and 4.00 mm2 * If female, participant must be incapable of pregnancy * If male, participant must agree to use an effective form of birth control during the study
Exclusion criteria
* Participant is unable to provide informed consent * Participant is less than 21 years of age or greater than 80 years of age * Participant is medically unable to comply with study procedures or follow-up visits * Participant was a study subject in any other clinical trial of an intervention (drug or device) within the last 6 months * Participant is pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ellipsoid zone (area of IS/OS loss) as measured by en face imagining by SDOCT in study eye(s) | 24 months | Change in the ellipsoid zone (area of IS/OS loss) from baseline to month 24 as measured by en face imaging by SDOCT in study eye(s) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Retinal sensitivity (dB) as measured by microperimetry | 12 and 24 months | Change in retinal sensitivity (dB) as measured by microperimetry from baseline to Months 12 and 24. |
| Increase in ellipsoid zone | 12 and 24 months | Proportion of study eyes with a 35% or more increase from baseline in the ellipsoid zone at Months 12 and 24. |
| Visual Acuity | 12 and 24 months | Change in best corrected visual acuity (BCVA) from baseline to Months 12 and 24. |
| Reading Speed | 12 and 24 Months | Change in reading speed as measured by the IReST from baseline to Months 12 and 24. |
| Ellipsoid zone | 12 months | Change in the ellipsoid zone from baseline to Month 12. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Electroretinogram changes | 6, 12 and 24 Months | Electroretinogram (ERG) changes from baseline to Months 6, 12 and 24, in selected clinics/participants. |
| National Eye Institute Visual Functioning Questionnaire | 12 and 24 months | Change in NEI VFQ (overall and subscale) from baseline to Months 12 and 24. |
| Cone density as measured by AOSLO | 12 and 24 Months | Change in cone density as measured by AOSLO from baseline to Months 12 and 24, in selected participants. |
Countries
Australia, United States
Outcome results
None listed