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NCT02140164 · ClinicalTrials.gov registry record · Phase 1

Study of Oral Minocycline in Treating Bilateral Cystoid Macular Edema Associated With Retinitis Pigmentosa

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

Completed
Registry status
Phase 1
Development phase
7
Enrollment target

NCT02140164 is a Phase 1 study that has completed, run by National Eye Institute (NEI). The registered enrollment target is 7 participants.

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The verdict

NCT02140164, a Phase 1 study, has completed, sponsored by National Eye Institute (NEI).

COMPLETED
Registry status
Phase 1
Development phase
7 participants
Enrollment target

Study Summary

Background: \- Some people with retinitis pigmentosa (RP) have macular edema (swelling) in the central retina. This can cause decreased central vision. The cause of macular edema is unknown, but may involve inflammation. The drug minocycline might help prevent inflammation and therefore might help treat macular edema and improve central visual function . Objectives: \- To see if minocycline helps people with RP and macular edema. Eligibility: \- People 12 years and older with RP who have macular edema in at least on eye. Design: * Participants will be screened with medical and eye disease history. They will have an eye exam and blood tests. One eye with macular edema will be the study eye. If both eyes are affected, one will be designated the study eye. * Participants will visit the clinic at least 9 times over at least 14 months. The first 3 study visits will be monthly, then every 2 months. * Participants will start taking minocycline after visit 3. They will take 1 pill twice daily for at least 1 year. * Participants will keep a medicine diary and bring it to each visit with their pill bottle and unused pills. At each study visit, participants will have some or all of the following tests: * eye and thyroid exams * blood and pregnancy tests * microperimetry: participants will press a button when they see a light on a computer screen * visual field measurement: participants will look at spots on a white screen to test side vision * electroretinogram: A person will be dark adapted by sitting in the dark for 30 minutes. After the placement of numbing eye drops, special contact lenses will be placed . The participant will watch flashing lights and recordings will be made.

Interventions

  • DRUG Minocycline

Trial Details

FieldValue
Enrollment Target 7 participants
Start Date 2014-05
Est. Completion 2016-06
Phase Phase 1

Sponsor

National Eye Institute (NEI)

221 total trials

What the Registry Record Tells You About NCT02140164

The ClinicalTrials.gov registry entry for NCT02140164 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Eye Institute (NEI), which has 221 total studies on file at ClinicalTrials.gov.

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

NCT02140164 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02140164 about?

NCT02140164 is a clinical study titled "Study of Oral Minocycline in Treating Bilateral Cystoid Macular Edema Associated With Retinitis Pigmentosa". Background: \- Some people with retinitis pigmentosa (RP) have macular edema (swelling) in the central retina. This can cause decreased central vision. The cause of macular edema is unknown, but may involve inflammation. The drug minocycline might help prevent inflammation and therefore might help ...

What is the current status of trial NCT02140164?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2014-05. Estimated completion is 2016-06.

What interventions are being tested in trial NCT02140164?

The interventions under investigation include: Minocycline (DRUG).

Who is sponsoring clinical trial NCT02140164?

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

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.