A Phase 2 interventional study of Ciliary neurotrophic factor (CNTF) and Sham procedure in Macular Telangiectasia Type 2, sponsored by Neurotech Pharmaceuticals. Completed at 11 sites in 2 countries. Open to participants aged 21 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-09-12.
Sponsored by Neurotech Pharmaceuticals · Phase 2, Interventional, and Treatment
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.
153 studies on the registry are indexed under Telangiectasis; 16 are open to participants now.
This study's enrollment of 67 is above the median of 30 across 107 interventional studies indexed under Telangiectasis.
Browse Telangiectasis studies →Neurotech Pharmaceuticals is the lead sponsor of 13 studies on the registry; 1 is open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 7 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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) · Device: NT-501 Implant · Procedure: NT-501 Implant procedure
Non-penetrating sham procedure to mimic implant procedure
Procedure: Sham procedure
Ciliary neurotrophic factor released from NT-501 encapsulated cell implant
Sham surgery for Sham arm
NT-501 encapsulated cell implant
Surgery to implant device for NT-501 encapsulated cell implant releasing human ciliary neurotrophic factor arm
Ellipsoid zone (area of IS/OS loss) as measured by en face imagining by SDOCT in study eye(s)
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)
Time frame: 24 months
Ellipsoid zone
Change in the ellipsoid zone from baseline to Month 12.
Time frame: 12 months
Retinal sensitivity (dB) as measured by microperimetry
Change in retinal sensitivity (dB) as measured by microperimetry from baseline to Months 12 and 24.
Time frame: 12 and 24 months
Increase in ellipsoid zone
Proportion of study eyes with a 35% or more increase from baseline in the ellipsoid zone at Months 12 and 24.
Time frame: 12 and 24 months
Visual Acuity
Change in best corrected visual acuity (BCVA) from baseline to Months 12 and 24.
Time frame: 12 and 24 months
Visual Acuity
Proportion of study eyes with 15 or more letter loss from baseline in BCVA at Months 12 and 24.
Time frame: 12 and 24 Months
Visual Acuity
Proportion of study eyes with 10 or more letter loss from baseline in BCVA at Months 12 and 24.
Time frame: 12 and 24 Months
Reading Speed
Change in reading speed as measured by the IReST from baseline to Months 12 and 24.
Time frame: 12 and 24 Months
Cone density as measured by AOSLO
Change in cone density as measured by AOSLO from baseline to Months 12 and 24, in selected participants.
Time frame: 12 and 24 Months
National Eye Institute Visual Functioning Questionnaire
Change in NEI VFQ (overall and subscale) from baseline to Months 12 and 24.
Time frame: 12 and 24 months
Electroretinogram changes
Electroretinogram (ERG) changes from baseline to Months 6, 12 and 24, in selected clinics/participants.
Time frame: 6, 12 and 24 Months
This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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Neurotech Pharmaceuticals