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A Phase 2 Multicenter Randomized Clinical Trial of CNTF for MacTel

N

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

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

Trial contacts and locations

11

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Data sourced from clinicaltrials.gov

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