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Interferon Gamma-1b Administered Topically for Macular Edema/Intraretinal Schisis Cysts in Rod-Cone Dystrophy (RCD) and Enhanced S-Cone Syndrome (ESCS)

NCT02338973 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2019-08-13

Study results available
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Summary

Background:

\- People with rod-cone dystrophy (RCD) or enhanced S-cone syndrome (ESCS) have excess fluid under the retina of their eye. This can cause vision loss. The medicine interferon gamma-1b may help people with these diseases.

Objectives:

\- To see if interferon gamma-1b eyedrops are safe for people with RCD or ESCS. To see if the medicine can decrease retina fluid and help prevent vision loss.

Eligibility:

\- People at least 12 years old with RCD or ESCS. Those with ESCS must have two mutations in the NR2E3 gene.

Design:

* Participants will be screened with medical history, physical exam, eye exam, and blood tests.
* Participants will stay at NIH for 3 days and get the first eyedrops.
* Participants will give themselves 4 study eyedrops 4 times daily for 2 weeks and keep a diary.
* Participants will have 5 outpatient visits over 8 weeks, 2 of which are telephone assessments. They may have:
* Repeats of screening tests.
* Questionnaires.
* Small piece of skin removed.
* Eye exams, including eye dilation and tasks on computer screens.
* Fluorescein angiography. A dye injected into an arm vein will travel to the blood vessels in the eyes. A camera will take pictures.
* Electroretinography. Participants will sit in the dark wearing eyepatches. A small electrode will be taped to the forehead. After 30 minutes, researchers will remove the eyepatches and put in numbing eyedrops and contact lenses. Participants will watch flashing lights.
* Electrooculography. Electrodes will be attached outside of the eyes and eye function will be measured in the dark and the light.
* Participants will have a follow-up visit after 52 weeks.

Conditions

  • Inherited Ophthalmic Diseases
  • Inherited Retinal Degeneration

Interventions

DRUG

Interferon gamma-1b

Sponsors & Collaborators

  • National Eye Institute (NEI)

    lead NIH

Principal Investigators

  • Wadih Zein, M.D. · National Eye Institute (NEI)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-14
Primary Completion
2018-06-01
Completion
2018-07-26
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02338973 on ClinicalTrials.gov