CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 42 enrolled
Drug / intervention
PredA + Kelacdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01769352
NCT01769352Phase 3Completed
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Treatment of Post-surgical Cystoid Macular Edema With Topical Steroids Trial (TEMPEST-1)

Johns Hopkins University·interventional·Posted Jan 16, 2013·Updated Sep 15, 2017

In Brief

A Phase 3 clinical trial evaluating PredA + Kelac for Post-surgical Cystoid Macular Edema (PSCME). Completed, enrolled 42 participants across 1 site.

Detailed Summary

The purpose of this study is to compare the change in visual acuity of patients with post surgical cystoid macular edema who will be treated with two different regimens.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPost-surgical Cystoid Macular Edema (PSCME)
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 16, 2013
Enrollment StartAug 1, 2012
Primary CompletionApr 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 13.5 years ago

Interventions

PredA + Kelacdrug

At week 12, patients will be determined to be resolved, improving/stabilized or treatment failures. Patients who have complete resolution of edema will begin treatment withdrawl. Improving/stabilizing patients will maintain current therapy. Treatment failure Group 2 patients will move to Group 3 to receive PredA q1h WA + Kelac qid starting at week 12. Treatment failure Group 1 patients will be exited from the trial so that alternative therapy can be given.