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NCT02338973 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by National Eye Institute (NEI).

Terminated
Registry status
Phase 1
Development phase
4
Enrollment target

NCT02338973: Clinical Trial Phase 1 study, sponsored by National Eye Institute (NEI).

NCT02338973 is a Phase 1 study that was terminated before completion, run by National Eye Institute (NEI). The registered enrollment target is 4 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02338973, a Phase 1 study, was terminated before completion, sponsored by National Eye Institute (NEI).

TERMINATED
Registry status
Phase 1
Development phase
4 participants
Enrollment target

Study 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.

Primary Outcome

The number and severity of adverse events related to the investigation product (IP).

Interventions

  • DRUG Interferon gamma-1b

Trial Details

FieldValue
Enrollment Target 4 participants
Start Date 2015-01-14
Est. Completion 2018-07-26
Phase Phase 1
National Eye Institute (NEI)

221 total trials

Why NCT02338973 stopped before completion

NCT02338973 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower).

The record links to 0 conditions, and to 1 intervention - of which Interferon gamma-1b is the first listed.

NCT02338973 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02338973 about?

NCT02338973 is a clinical study titled "Interferon Gamma-1b Administered Topically for Macular Edema/Intraretinal Schisis Cysts in Rod-Cone Dystrophy (RCD) and Enhanced S-Cone Syndrome (ESCS)". 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 ...

What is the current status of trial NCT02338973?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2015-01-14. Estimated completion is 2018-07-26.

What interventions are being tested in trial NCT02338973?

The interventions under investigation include: Interferon gamma-1b (DRUG).

Who is sponsoring clinical trial NCT02338973?

This trial is sponsored by National Eye Institute (NEI), which has 221 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02338973's enrollment target sits among peer trials

4 1995th of 2000 higher than 2 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02338973, the US trial registry maintained by the National Library of Medicine. NCT02338973 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.