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Completed

NCT Number: NCT01769352

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.

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Key information

Conditions

Post-surgical Cystoid Macular Edema (PSCME) Eye Diseases Macular Degeneration Macular Edema Retinal Degeneration Retinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Wilmer Eye Institute

Baltimore, Maryland, 21287, United States

About this study

Compare the mean change in BCVA over 12 weeks of Prednisolone Acetate 1% q1h (every hour) WA (While Awake) + Ketorolac 0.5% qid (four times a day) versus Prednisolone Acetate qid + Ketorolac qid for post surgical cystoid macular edema.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age more than or equal to 18 years
  • Diagnosis of PSCME in study eye confirmed by FA showing leakage from retinal vessels resulting in pooling of dye in the fovea and Spectralis SD-OCT showing intraretinal fluid in or around the fovea.
  • BCVA score in the study eye of 20/30 to 20/400 inclusive (Snellen equivalents using the ETDRS protocol at a distance of 4 meters).
  • In the opinion of the investigator, decreased vision in the study eye is due to foveal thickening from PSCME and not to any other reason.

Exclusion criteria

  • Any patient who has other retinal diseases known to cause macular edema (choroidal neovascularization, vein occlusion, diabetic macular edema in the study eye). Patients with nonexudative Age Related Macular Degeneration (ARMD) or non-proliferative diabetic retinopathy without macular edema can be included in the study.
  • Other reason for decreased visual acuity (such as amblyopia, foveal atrophy, optic atrophy).
  • Pre-existing diagnosis of glaucoma in the study eye
  • Inability to comply with study or follow up procedures
  • Pregnancy (Women of child bearing age will be asked to take a urine pregnancy test prior to enrolling in the study).

Treatment and study plan

PredA + Kelac

Drug

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.

Other names: Acular, Acuvail, Pred Forte, Omnipred, Pred Mild

Primary outcomes

  1. Mean Change in Best-Corrected Visual Acuity at Week 12 From Baseline

    Time frame: Baseline and Week 12

    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.

Secondary outcomes

  1. Mean Change in Central Subfield Thickness at Week 12 From Baseline

    Time frame: Baseline and Week 12

    Mean Change in Central Subfield Thickness (µm) at Week 12 from Baseline

  2. Mean Change in Intraocular Pressure at Week 12 From Baseline

    Time frame: Baseline and Week 12

    Mean Change in Intraocular Pressure (IOP) at week 12 from Baseline

  3. Mean Change in Best-Corrected Visual Acuity Between Week 12 and Week 48

    Time frame: Week 12 and Week 48

    Mean Change in Best-Corrected Visual Acuity (Letters Score) between Week 12 and Week 48. 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.

  4. Mean Change in Central Subfield Thickness (CST) Between Week 12 and Week 48

    Time frame: Week 12 and Week 48

    Mean Change in Central Subfield Thickness (CST,µm) between week 12 and week 48

  5. Mean Change in Intraocular Pressure Between Week 12 and Week 24

    Time frame: Week 12 and Week 48

    Mean Change in Intraocular Pressure (IOP) between week 12 and week 24

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Acronym: TEMPEST

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jan 16, 2013
Registry last updated
Sep 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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