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

This study is currently recruiting participants.
Verified November 2013 by Johns Hopkins University
Sponsor:
Information provided by (Responsible Party):
Peter A Campochiaro, MD, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01769352
First received: January 14, 2013
Last updated: November 1, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Post-surgical Cystoid Macular Edema (PSCME)
Drug: PredA + Kelac
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Post-surgical Cystoid Macular Edema With Topical Steroids Trial (TEMPEST)

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Mean change from baseline in BCVA [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 46
Study Start Date: August 2012
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PredA q1h WA + Kelac qid
PredA q1h WA + Kelac qid
Drug: PredA + Kelac
Active Comparator: PredA qid + Kelac qid
PredA qid + Kelac qid
Drug: PredA + Kelac

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01769352

Contacts
Contact: Gulnar Hafiz, MD, MPH ghafiz1@jhmi.edu

Locations
United States, Maryland
Wilmer Eye Institute Recruiting
Baltimore, Maryland, United States, 21287
Contact: Gulnar Hafiz, MD MPH         
Principal Investigator: Peter A Campochiaro, MD         
Sub-Investigator: Claudia M Krispel, MD, PHD         
Sub-Investigator: Raafay Sophie, MD         
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Peter A Campochiaro, MD Johns Hopkins University
  More Information

No publications provided

Responsible Party: Peter A Campochiaro, MD, Principal Investigator, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01769352     History of Changes
Other Study ID Numbers: NA_00074523
Study First Received: January 14, 2013
Last Updated: November 1, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on April 23, 2014