Extension Study of NT-501 Ciliary Neurotrophic Factor (CNTF) Implant for Macular Telangiectasia (MacTel)

Neurotech

Status and phase: Completed; Phase 2

Conditions: MacTel (Macular Telangiectasia) Type 2

Treatments: Biological: Ciliary neurotrophic factor (CNTF); Procedure: Surgery

Study type: Interventional

Funder types: Industry

Identifiers

NCT03071965

NTMT-01/02E

Details and patient eligibility

About

This was a prospective, multicenter, single-masked, sham-controlled extension study designed to provide long-term safety and efficacy follow-up data for subjects with MacTel who had NT-501 implanted intraocularly and/or underwent sham surgery in the respective precursor study (NTMT-01 or NTMT-02).

A substudy was conducted in which subjects enrolled in study (NTMT-02), who had 1 study-eligible eye that underwent sham surgery, were offered the option to have NT-501 implanted in the same study eye. Of the 19 subjects who had 1 study-eligible eye and underwent sham surgery in the Cohort 2 precursor study (NTMT-02), 16 subjects elected to have NT-501 implanted in the same study eye during the substudy

Enrollment: 70 patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Previously enrolled in the NTMT-01 or NTMT-02 protocol and received the NT-501 implant and/or underwent a Sham procedure
• Participant must be offered sufficient opportunity to review and to understand the informed consent form, agree to the form's contents, and provide written informed consent.

Exclusion criteria

• There are no Exclusion Criteria

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

Cohort 1

Experimental group

Description:

Participants completed protocol NTMT-01. All participants received surgery to implant NT-501. All participants received ciliary neurotrophic factor (CNTF).

Treatment:

Procedure: Surgery

Biological: Ciliary neurotrophic factor (CNTF)

Procedure: Surgery

Cohort 2

Experimental group

Description:

Participants completed protocol NTMT-02. Participants for cohort 2 arm were either: * NT-501 group: included subjects who each had 1 study-eligible eye that had NT-501 implanted and a fellow eye that did not undergo any study intervention. * Sham group: included subjects who each had 1 study-eligible eye that underwent sham surgery and a fellow eye that did not undergo any study intervention. * Sham+NT-501 group: included subjects who had both eyes that were study-eligible, and had NT-501 implanted in 1 eye and underwent sham surgery in the contralateral eye.

Treatment:

Procedure: Surgery

Biological: Ciliary neurotrophic factor (CNTF)

Procedure: Surgery