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NCT02294656 · ClinicalTrials.gov registry record · Phase 1
Acute Pseudophakic Cystoid Macular Edema Treatment Trial: Intravitreal Ranibizumab Versus Triamcinolone Acetonide
A Phase 1 study of Cystoid Macular Edema, sponsored by Soll Eye.
- Completed
- Registry status
- Phase 1
- Development phase
- 4
- Enrollment target
- 1
- Study location
NCT02294656: Completed Phase 1 study of Cystoid Macular Edema, sponsored by Soll Eye.
NCT02294656 is a Phase 1 study of Cystoid Macular Edema that has completed, run by Soll Eye. 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). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02294656, a Phase 1 study of Cystoid Macular Edema, has completed, sponsored by Soll Eye.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 4 participants
- Enrollment target
- 1
- Study location
Study Summary
This is an open-label, Phase I/II study evaluating intravitreal ranibizumab (R) vs. intravitreal Triesence (triamcinolone acetonide) (T) in subjects with acute pseudophakic cystoid macular edema (CME). Twenty consented patients with acute CME after phacoemulsification cataract surgery with posterior chamber intraocular lens implantation (PE/PCIOL) will be randomized 1:1 to treatment with R or T. R patients will receive three monthly R injections, followed by PRN dosing. T patients will receive PRN injections every 3 months. Clinical CME is defined as clinically evident CME, with visual acuity (VA) typically in the 20/40 to 20/200 range. Re-treatment criteria will include clinically evident worsening of CME, combined with any of the following: * Any increase in spectral domain ocular coherence tomography (OCT) central macular thickness (CMT) * Any observable fluid on OCT * Any qualitatively increased perifoveal leakage/pooling on fluorescein angiography (FA). Patients will be followed monthly through 12 months.
Primary Outcome
To assess the safety of intravitreal R and T for the treatment of acute pseudophakic cystoid macular edema by evaluating: * Incidence and severity of ocular adverse events, as identified by eye examination * Incidence and severity of other adverse events, as identified by physical examination, subject reporting, and changes in vital signs
Conditions Studied
Interventions
- DRUG Ranibizumab,
- DRUG Triamcinolone acetonide
Study Locations (1)
Pennsylvania
- Soll Eye - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2014-11 |
| Est. Completion | 2018-09 |
| Phase | Phase 1 |
What the finished NCT02294656 record still lists
NCT02294656 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 1 condition, with Cystoid Macular Edema appearing as the primary indexed condition, and to 2 interventions - of which Ranibizumab, is the first listed.
NCT02294656 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT02294656 about?
NCT02294656 is a clinical study titled "Acute Pseudophakic Cystoid Macular Edema Treatment Trial: Intravitreal Ranibizumab Versus Triamcinolone Acetonide". This is an open-label, Phase I/II study evaluating intravitreal ranibizumab (R) vs. intravitreal Triesence (triamcinolone acetonide) (T) in subjects with acute pseudophakic cystoid macular edema (CME). Twenty consented patients with acute CME after phacoemulsification cataract surgery with posterior...
What is the current status of trial NCT02294656?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2014-11. Estimated completion is 2018-09.
What conditions does trial NCT02294656 study?
This clinical trial studies the following conditions: Cystoid Macular Edema.
What interventions are being tested in trial NCT02294656?
The interventions under investigation include: Ranibizumab, (DRUG), Triamcinolone acetonide (DRUG).
Who is sponsoring clinical trial NCT02294656?
This trial is sponsored by Soll Eye, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02294656 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT02294656's enrollment target sits among peer trials
4 1995th of 2000 higher than 2 of 2,000 other Phase 1 trials
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