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Completed

NCT Number: NCT01949324

A Phase 2 Multicenter Randomized Clinical Trial of CNTF for MacTel

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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Key information

Conditions

Macular Telangiectasia Type 2

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Save Sight Institute, Sydney, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ciliary neurotrophic factor (CNTF)

Biological

Ciliary neurotrophic factor released from NT-501 encapsulated cell implant

Sham Procedure

Procedure

Sham surgery for Sham arm

NT-501 Implant

Device

NT-501 encapsulated cell implant

NT-501 Implant procedure

Procedure

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

Primary outcomes

  1. Ellipsoid zone (area of IS/OS loss) as measured by en face imagining by SDOCT in study eye(s)

    Time frame: 24 months

    Change in the ellipsoid zone (area of IS/OS loss) from baseline to month 24 as measured by en face imaging by SDOCT in study eye(s)

Secondary outcomes

  1. Ellipsoid zone

    Time frame: 12 months

    Change in the ellipsoid zone from baseline to Month 12.

  2. Retinal sensitivity (dB) as measured by microperimetry

    Time frame: 12 and 24 months

    Change in retinal sensitivity (dB) as measured by microperimetry from baseline to Months 12 and 24.

  3. Increase in ellipsoid zone

    Time frame: 12 and 24 months

    Proportion of study eyes with a 35% or more increase from baseline in the ellipsoid zone at Months 12 and 24.

  4. Visual Acuity

    Time frame: 12 and 24 months

    Change in best corrected visual acuity (BCVA) from baseline to Months 12 and 24.

  5. Visual Acuity

    Time frame: 12 and 24 Months

    Proportion of study eyes with 15 or more letter loss from baseline in BCVA at Months 12 and 24.

  6. Visual Acuity

    Time frame: 12 and 24 Months

    Proportion of study eyes with 10 or more letter loss from baseline in BCVA at Months 12 and 24.

  7. Reading Speed

    Time frame: 12 and 24 Months

    Change in reading speed as measured by the IReST from baseline to Months 12 and 24.

Other outcomes

  1. Cone density as measured by AOSLO

    Time frame: 12 and 24 Months

    Change in cone density as measured by AOSLO from baseline to Months 12 and 24, in selected participants.

  2. National Eye Institute Visual Functioning Questionnaire

    Time frame: 12 and 24 months

    Change in NEI VFQ (overall and subscale) from baseline to Months 12 and 24.

  3. Electroretinogram changes

    Time frame: 6, 12 and 24 Months

    Electroretinogram (ERG) changes from baseline to Months 6, 12 and 24, in selected clinics/participants.

Sponsors and collaborators

Lead sponsor

Neurotech Pharmaceuticals

Industry

Collaborators

  • The Emmes Company, LLC
  • The Lowy Medical Research Institute Limited

Registry information

Official study title

A Phase 2 Multicenter Randomized Clinical Trial of Ciliary Neurotrophic Factor (CNTF) for Macular Telangiectasia Type 2 (MacTel)

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Sep 24, 2013
Registry last updated
Sep 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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