A Phase 2 Multicenter Randomized Clinical Trial of CNTF for MacTel

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2017-05-22

Brief Summary

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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.

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Detailed Description

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Conditions

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Macular Telangiectasia Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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NT-501 Implant procedure

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).

Group Type EXPERIMENTAL

Ciliary neurotrophic factor (CNTF)

Intervention Type BIOLOGICAL

Ciliary neurotrophic factor released from NT-501 encapsulated cell implant

NT-501 Implant

Intervention Type DEVICE

NT-501 encapsulated cell implant

NT-501 Implant procedure

Intervention Type PROCEDURE

Surgery to implant device for NT-501 encapsulated cell implant releasing human ciliary neurotrophic factor arm

Sham procedure

Non-penetrating sham procedure to mimic implant procedure

Group Type SHAM_COMPARATOR

Sham procedure

Intervention Type PROCEDURE

Sham surgery for Sham arm

Interventions

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Ciliary neurotrophic factor (CNTF)

Ciliary neurotrophic factor released from NT-501 encapsulated cell implant

Intervention Type BIOLOGICAL

Sham procedure

Sham surgery for Sham arm

Intervention Type PROCEDURE

NT-501 Implant

NT-501 encapsulated cell implant

Intervention Type DEVICE

NT-501 Implant procedure

Surgery to implant device for NT-501 encapsulated cell implant releasing human ciliary neurotrophic factor arm

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No