Retinal Imaging of Subjects Implanted With Ciliary Neurotrophic Factor (CNTF)-Releasing Encapsulated Cell Implant for Early-stage Retinitis Pigmentosa
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01530659|
Recruitment Status : Active, not recruiting
First Posted : February 10, 2012
Last Update Posted : November 29, 2018
|Condition or disease||Intervention/treatment||Phase|
|Retinitis Pigmentosa Usher Syndrome Type 2 Usher Syndrome Type 3||Drug: NT-501 Procedure: Sham||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Photoreceptor Structure in A Phase 2 Study of Encapsulated Human NTC-201 Cell Implants Releasing Ciliary Neurotrophic Factor (CNTF) for Participants With Retinitis Pigmentosa Using Rates of Change in Cone Spacing and Density|
|Study Start Date :||January 2012|
|Estimated Primary Completion Date :||August 2019|
|Estimated Study Completion Date :||August 2019|
Encapsulated cell therapy that delivers ciliary neurotrophic factor to the retina
Study participants will undergo surgery to have an NT-501 Encapsulated Cell Therapy implant placed into the study eye.
Other Name: CNTF, Encapsulated Cell Therapy, ECT
Sham Comparator: Sham
Non-penetrating sham procedure to mimic implant procedure in the other eye.
- Cone photoreceptor preservation [ Time Frame: 6, 12, 18, 24 and 30 months post implant ]Evaluation of the changes (if present)in cone photoreceptor preservation in the CNTF-treated eye vs. the sham eye as measured by AOSLO.
- Safety of the implanted NT-501 investigational product [ Time Frame: 6, 12, 18, 24, 30 and 36 months post implant ]Safety will be measured,in part, by the presence or absence of rejection or extrusion of the implanted NT-501 device.
- Change(s) in ocular function [ Time Frame: 6, 12, 18, 24, 30 and 36 months post implant ]
Change(s) in visual acuity and change in perimetry assessed by:
- Mean, median and distribution of change in best corrected visual acuity (BCVA)
- Changes in visual field using perimetry,
- Changes in the outer nuclear layer thickness as measure by sdOCT,
- Changes in full-field electroretinography (ERG) from Baseline to 12 and 24-months post implant
- The presence of peri-implant fibrosis that blocks the visual axis or affects the lens or retina
- Adverse events affecting ocular function which are thought to be potentially related to the implant
- Local or Systemic Toxicity [ Time Frame: 6, 12, 18, 24, 30 and 36 months post implant ]Local or systemic toxicities considered serious adverse events that are potentially related to the implant
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): NCT01530659
|United States, California|
|University of California, San Francisco|
|San Francisco, California, United States, 94143|
|Principal Investigator:||Jacque Duncan, MD||University of California, San Francisco|