A Study to Determine the Safety and Efficacy of NT-501 in Macular Telangiectasia Type 2 - Protocol A
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|ClinicalTrials.gov Identifier: NCT03316300|
Recruitment Status : Completed
First Posted : October 20, 2017
Last Update Posted : February 8, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Macular Telangiectasia Type 2||Combination Product: NT-501 Procedure: Sham||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||115 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||A Phase III Multicenter Randomized, Sham Controlled, Study to Determine the Safety and Efficacy of NT-501 in Macular Telangiectasia Type 2|
|Actual Study Start Date :||November 24, 2017|
|Actual Primary Completion Date :||August 31, 2022|
|Actual Study Completion Date :||September 23, 2022|
Combination Product: NT-501
Surgery to receive one NT-501 device implant.
|Sham Comparator: Sham||
Non-penetrating sham procedure to mimic implant procedure.
- Rate of Change in Ellipsoid Zone (EZ) Area Loss [ Time Frame: Baseline through 24 months. ]Rate of change in EZ area loss as measured by en face imaging by Spectral-Domain Optical Coherence Tomography (SD-OCT) in the study eye.
- Mean Change in Aggregate Sensitivity of Microperimetry [ Time Frame: Baseline through 24 months. ]NT-501 compared to sham relative to mean change in aggregate sensitivity of microperimetry within the EZ line break area.
- Mean Change in Reading Speed [ Time Frame: Baseline through 24 months. ]NT-501 compared to sham relative to mean change in reading speed assessed using International Reading Speed Texts (IReST) cards.
- National Eye Institute-Visual Function Questionnaire (NEI-VFQ) [ Time Frame: Baseline through 24 months. ]NT-501 compared to sham relative to mean change in the NEI-VFQ near activities subscale score.
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|Ages Eligible for Study:||21 Years to 80 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Key Inclusion Criteria:
- Participant must have at least one study eye with a positive diagnosis of MacTel Type 2
- Participant must have an Inner Segment - Outer Segment Junction Line (IS/OS) Photo Receptor (PR) break in the study eye(s) and en face EZ (area of IS/OS loss) as measured by spectral-domain optical coherence tomography (SDOCT) between 0.16 mm^2 and 2.00 mm^2
- Participant's best corrected visual acuity is 54 letter score or better (20/80 or better) as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) chart
Key Exclusion Criteria:
- Participant received intravitreal steroid therapy for non-neovascular MacTel within the last 3 months
- Participant has ever received intravitreal anti-vascular endothelial growth factor (VEGF) therapy in the study eye or has, within the past 3 months, received intravitreal anti-VEGF in the fellow eye
- Participant has evidence of ocular disease other than MacTel that, in the judgment of the examining physician, may confound the diagnosis, procedures or outcome of the study
- Participant was a study participant in any other clinical trial of an intervention (drug or device) within the last 6 months
- Participant is pregnant or breastfeeding
- Participant has a chronic requirement (eg ≥ 4 weeks at a time) for ocular medications
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03316300
|Principal Investigator:||Emily Chew, MD||National Eye Institute (NEI)|
|Responsible Party:||Neurotech Pharmaceuticals|
|Other Study ID Numbers:||
|First Posted:||October 20, 2017 Key Record Dates|
|Last Update Posted:||February 8, 2023|
|Last Verified:||October 2022|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||Yes|
Ciliary Neurotrophic Factor (CNTF)
Macular Telangiectasia (MacTel)