A Study of Encapsulated Cell Technology (ECT) Implant for Participants With Early Stage Retinitis Pigmentosa

• Register: ClinicalTrials.gov
• Last refreshed on: 28 November 2016
• Main ID: NCT00447980
• Date of registration: 09/03/2007
• Prospective Registration: No
• Primary sponsor: Neurotech Pharmaceuticals
• Public title: A Study of Encapsulated Cell Technology (ECT) Implant for Participants With Early Stage Retinitis Pigmentosa
• Scientific title: A Phase II/III Study of Encapsulated Human NTC-201 Cell Implants Releasing Ciliary Neurotrophic Factor (CNTF) for Participants With Retinitis Pigmentosa Using Visual Field Sensitivity as the Primary Outcome
• Date of first enrolment: January 2007
• Target sample size: 68
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00447980
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Weng Tao, MD, PhD
• Affiliation: Neurotech Pharmaceuticals

Key inclusion & exclusion criteria

Study inclusion / exclusion criteria:

Criteria for patients to qualify for the study include, but are not limited to:

- Over 18 years of age, and less than 65 years of age

- Diagnosis of retinitis pigmentosa, Usher Syndrome Type 2 or 3 or Choroideremia

- Visual acuity no worse than 20/63

- Experience with at least two full threshold Humphrey Visual Field 30-2 tests, one
completed within the year prior to enrolling in this study

The following criteria will exclude patients from the study:

- Pregnant or lactating females, or females planning to become pregnant during the
study or not using an acceptable method of contraception.

- Retinitis pigmentosa caused by a classic syndrome, including Usher Type I

- Other eye diseases including advanced cataract.

- Chronic systemic disease requiring continuous treatment with systemic steroids,
immunosuppressive medications or insulin.



Age minimum: 18 Years
Age maximum: 64 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Retinitis Pigmentosa

Intervention(s)

Drug: NT-501

Primary Outcome(s)

Change in Humphrey visual field sensitivity from baseline to month 12. [Time Frame: 12 months]

Secondary Outcome(s)

Change in vision-related quality of life [Time Frame: 12 to 24 months]

Change in ERG [Time Frame: 12 to 24 months]

Change in visual field sensitivity [Time Frame: 24 months]

Mean, median and distribution of change in Best Corrected Visual Acuity [Time Frame: 12 to 24 months]

Change in inflammation [Time Frame: 12 to 24 months]

Change in OCT [Time Frame: 12 to 24 months]

Secondary ID(s)

CNTF 4

Source(s) of Monetary Support

Please refer to primary and secondary sponsors