A Phase 2 Multicenter Randomized Clinical Trial of CNTF for MacTel

Neurotech

Status and phase: Completed; Phase 2

Conditions: Macular Telangiectasia Type 2

Treatments: Device: NT-501 Implant; Procedure: Sham procedure; Biological: Ciliary neurotrophic factor (CNTF); Procedure: NT-501 Implant procedure

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01949324

NTMT-02

Details and patient eligibility

About

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.

Enrollment: 67 patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participant must be offered sufficient opportunity to review and to understand the informed consent form, agree to the form's contents and sign the protocol's informed consent
• Participant must have at least one study eye with a positive diagnosis of MacTel Type 2
• Participant must have an IS/OS PR break in the study eye(s) and en face ellipsoid zone (area of IS/OS loss) as measured by SDOCT between 0.16 mm2 and 4.00 mm2
• If female, participant must be incapable of pregnancy
• If male, participant must agree to use an effective form of birth control during the study

Exclusion criteria

• Participant is unable to provide informed consent
• Participant is less than 21 years of age or greater than 80 years of age
• Participant is medically unable to comply with study procedures or follow-up visits
• Participant was a study subject in any other clinical trial of an intervention (drug or device) within the last 6 months
• Participant is pregnant or breastfeeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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67 participants in 2 patient groups

NT-501 Implant procedure

Experimental group

Description:

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).

Treatment:

Procedure: NT-501 Implant procedure

Device: NT-501 Implant

Biological: Ciliary neurotrophic factor (CNTF)

Sham procedure

Sham Comparator group

Description:

Non-penetrating sham procedure to mimic implant procedure

Treatment:

Procedure: Sham procedure