A Phase 2 Multicenter Randomized Clinical Trial of CNTF for MacTel
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|ClinicalTrials.gov Identifier: NCT01949324|
Recruitment Status : Completed
First Posted : September 24, 2013
Last Update Posted : September 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Macular Telangiectasia Type 2||Biological: Ciliary neurotrophic factor (CNTF) Procedure: Sham procedure Device: NT-501 Implant Procedure: NT-501 Implant procedure||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||67 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Phase 2 Multicenter Randomized Clinical Trial of Ciliary Neurotrophic Factor (CNTF) for Macular Telangiectasia Type 2 (MacTel)|
|Study Start Date :||April 2014|
|Actual Primary Completion Date :||April 14, 2017|
|Actual Study Completion Date :||May 22, 2017|
Experimental: NT-501 Implant procedure
The investigational product is the NT-501 encapsulated cell system which consists of cells encapsulated within a semi-permeable polymer membrane and supportive matrices. NT-501 contains NTC-201 cells that were derived from the NTC-200 cell line by genetic modification so as to secrete recombinant human ciliary neurotrophic factor (CNTF).
Biological: Ciliary neurotrophic factor (CNTF)
Ciliary neurotrophic factor released from NT-501 encapsulated cell implant
Device: NT-501 Implant
NT-501 encapsulated cell implant
Procedure: NT-501 Implant procedure
Surgery to implant device for NT-501 encapsulated cell implant releasing human ciliary neurotrophic factor arm
Sham Comparator: Sham procedure
Non-penetrating sham procedure to mimic implant procedure
Procedure: Sham procedure
Sham surgery for Sham arm
- Ellipsoid zone (area of IS/OS loss) as measured by en face imagining by SDOCT in study eye(s) [ Time Frame: 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)
- Ellipsoid zone [ Time Frame: 12 months ]Change in the ellipsoid zone from baseline to Month 12.
- Retinal sensitivity (dB) as measured by microperimetry [ Time Frame: 12 and 24 months ]Change in retinal sensitivity (dB) as measured by microperimetry from baseline to Months 12 and 24.
- Increase in ellipsoid zone [ Time Frame: 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 [ Time Frame: 12 and 24 months ]Change in best corrected visual acuity (BCVA) from baseline to Months 12 and 24.
- Visual Acuity [ Time Frame: 12 and 24 Months ]Proportion of study eyes with 15 or more letter loss from baseline in BCVA at Months 12 and 24.
- Visual Acuity [ Time Frame: 12 and 24 Months ]Proportion of study eyes with 10 or more letter loss from baseline in BCVA at Months 12 and 24.
- Reading Speed [ Time Frame: 12 and 24 Months ]Change in reading speed as measured by the IReST from baseline to Months 12 and 24.
- Cone density as measured by AOSLO [ Time Frame: 12 and 24 Months ]Change in cone density as measured by AOSLO from baseline to Months 12 and 24, in selected participants.
- National Eye Institute Visual Functioning Questionnaire [ Time Frame: 12 and 24 months ]Change in NEI VFQ (overall and subscale) from baseline to Months 12 and 24.
- Electroretinogram changes [ Time Frame: 6, 12 and 24 Months ]Electroretinogram (ERG) changes from baseline to Months 6, 12 and 24, in selected clinics/participants.
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): NCT01949324
|United States, California|
|Jules Stein Eye Institute|
|Los Angeles, California, United States, 90095|
|United States, Florida|
|Miami, Florida, United States, 33136|
|United States, Georgia|
|Atlanta, Georgia, United States, 30322|
|United States, Maryland|
|National Eye Institute|
|Bethesda, Maryland, United States, 20892|
|United States, Massachusetts|
|Massachusetts Eye and Ear Infirmary, Retina Service|
|Boston, Massachusetts, United States, 02114|
|United States, Michigan|
|University of Michigan, Kellogg Eye Center|
|Ann Arbor, Michigan, United States, 48105|
|United States, Ohio|
|Retina Associates of Cleveland, Inc.|
|Beachwood, Ohio, United States, 44122|
|United States, Wisconsin|
|University of Wisconsin|
|Madison, Wisconsin, United States, 53705|
|Australia, New South Wales|
|Save Sight Institute|
|Sydney, New South Wales, Australia|
|Centre for Eye Research Australia|
|East Melbourne, Australia|
|Lions Eye Institute|