Evaluation of Safety of Ciliary Neurotrophic Factor Implants in the Eye

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00063765
• Date of registration: 03/07/2003
• Prospective Registration: No
• Primary sponsor: National Eye Institute (NEI)
• Public title: Evaluation of Safety of Ciliary Neurotrophic Factor Implants in the Eye
• Scientific title: A Phase I Study of NT-501-10 and NT-501-6A.02, Implants of Encapsulated Human NTC-210 Cells Releasing Ciliary Neurotrophic Factor (CNTF), in Patients With Retinitis Pigmentosa
• Date of first enrolment: June 2003
• Target sample size: 10
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00063765
• Study type: Interventional
• Study design: Endpoint Classification: Safety Study, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

United States

Key inclusion & exclusion criteria

INCLUSION CRITERIA:

1. To participate in this study, the participant must understand and sign the protocol's
informed consent (if the participant's vision is impaired to the point where it is
not possible to read the informed consent document, the informed consent document
will be read in its entirety to the participant).

2. Paticipant diagnosis consistent with retinitis pigmentosa (RP) characterized by the
following features:

1. progressive photoreceptor dysfunction an death

2. clinical degeneration of the outer retina

3. intraretinal 'bone-spicule' pigment

4. visual field constriction

5. night blindness

6. major reduction of both rod and cone electroretinogram (ERG) responses.

3. The first two participants have 20/400 vision or worse in the implant (study) eye
with the same or better in the fellow eye, while the remainder of the participants
will have visual acuity of 20/100 or worse.

4. Participant has an ERG less than 2 MV(28-32 Hz flicker)

5. Participant with central visual field of 40 degrees diameter or less with the
Goldmann V 4e stimulus (independent of a peripheral crescent of any size)

6. Participant medically able to undergo ophthalmic surgery.

EXCLUSION CRITERIA:

1. Participant less than 18 years of age.

2. Participant medically unable to comply with study procedures or follow-up visits.

3. Participant has glaucoma.

4. Participant is receiving oral or other insulin treatment for diabetes.

5. Participant has cataract and it interferes with the assessment of the posterior
segment inflammation using a standard slit lamp examination.

6. Participant has undergone intra-ocular lens replacement less than 6 months prior to
enrollment.

7. Participant has participated in any other clinical trial of a drug or device within
the last 6 months.

8. Participant is on chemotherapy.

9. Participant is on ocular medications known to be toxic to the lens, retina, or optic
nerve.

10. Participant who is pregnant.

11. Participant with retinal inflammatory diseases.

12. Participant with macula edema

13. Participant with history of malignancy (except study participants having a basal cell
carcinoma that was treated successfully, or other malignancy operated on and in
remission of 5 years prior to inclusion in the trial).

14. Participant is considered immunodeficient or has a known history of HIV.



Age minimum: N/A
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Retinitis Pigmentosa

Intervention(s)

Drug: Ciliary Neurotrophic Factor Implant NT-501

Secondary ID(s)

03-EI-0234

030234

Source(s) of Monetary Support

Please refer to primary and secondary sponsors