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NCT01769352 · ClinicalTrials.gov registry record · Phase 2

Treatment of Post-surgical Cystoid Macular Edema With Topical Steroids Trial (TEMPEST-1)

A Phase 2 study of Post-surgical Cystoid Macular Edema (PSCME), sponsored by Johns Hopkins University.

Completed
Registry status
Phase 2
Development phase
42
Enrollment target
1
Study location

NCT01769352: Completed Phase 2 study of Post-surgical Cystoid Macular Edema (PSCME), sponsored by Johns Hopkins University.

NCT01769352 is a Phase 2 study of Post-surgical Cystoid Macular Edema (PSCME) that has completed, run by Johns Hopkins University. The registered enrollment target is 42 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01769352, a Phase 2 study of Post-surgical Cystoid Macular Edema (PSCME), has completed, sponsored by Johns Hopkins University.

COMPLETED
Registry status
Phase 2
Development phase
42 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

Mean change in best-corrected visual acuity (Letter Score) at Week 12 from Baseline. The Early Treatment of Diabetic Retinopathy Study (ETDRS) score is measured on a scale from 5 to 100. The higher the score on this scale, the better is the patients vision.

Interventions

  • DRUG PredA + Kelac

Study Locations (1)

Maryland

  • Wilmer Eye Institute - Baltimore

Trial Details

FieldValue
Enrollment Target 42 participants
Start Date 2012-08
Est. Completion 2016-04
Phase Phase 2
Johns Hopkins University

1,448 total trials

What the finished NCT01769352 record still lists

NCT01769352 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower).

The record links to 1 condition, with Post-surgical Cystoid Macular Edema (PSCME) appearing as the primary indexed condition, and to 1 intervention - of which PredA + Kelac is the first listed.

NCT01769352 reports a single indexed study location in Maryland.

Frequently Asked Questions

What is clinical trial NCT01769352 about?

NCT01769352 is a clinical study titled "Treatment of Post-surgical Cystoid Macular Edema With Topical Steroids Trial (TEMPEST-1)". 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.

What is the current status of trial NCT01769352?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 42 participants. The study started on 2012-08. Estimated completion is 2016-04.

What conditions does trial NCT01769352 study?

This clinical trial studies the following conditions: Post-surgical Cystoid Macular Edema (PSCME).

What interventions are being tested in trial NCT01769352?

The interventions under investigation include: PredA + Kelac (DRUG).

Who is sponsoring clinical trial NCT01769352?

This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01769352 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT01769352's enrollment target sits among peer trials

42 1339th of 2000 higher than 649 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT01769352, the US trial registry maintained by the National Library of Medicine. NCT01769352 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.