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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: Completed Phase 1 study, sponsored by National Eye Institute (NEI).
NCT02140164 is a Phase 1 study that has completed, run by National Eye Institute (NEI). The registered enrollment target is 7 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Three visits (two pre-treatment and one baseline) were conducted prior to the receipt of investigational product (IP) and an average of the OCT measurements at these three visits was used as the pre-treatment value.
Interventions
- DRUG Minocycline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2014-05 |
| Est. Completion | 2016-06 |
| Phase | Phase 1 |
What the finished NCT02140164 record still lists
NCT02140164 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 1 intervention - of which Minocycline is the first listed.
NCT02140164 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02140164's enrollment target sits among peer trials
7 1972nd of 2000 higher than 27 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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