Ozurdex for Combined Pseudophakic Cystoid Macular Edema and Diabetic Macular Edema After Cataract Surgery

This study has been completed.
Sponsor:
Collaborator:
Allergan
Information provided by:
Northern California Retina Vitreous Associates
ClinicalTrials.gov Identifier:
NCT01284478
First received: January 25, 2011
Last updated: October 3, 2012
Last verified: October 2012
  Purpose

The purpose of the study is to determine where a sustained steroid delivery system (Ozurdex,Allergan) is safe and effective to treat Cystoid Macular Edema in diabetic patients after Cataract Surgery


Condition Intervention Phase
Pseudophakic Cystoid Macular Edema,
Diabetic Macular Edema
Drug: Dexamethasone Implant
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2 Study of Ozurdex for Combined Pseudophakic Cystoid Macula Edema and Diabetic Macula Edema After Cataract Surgery

Resource links provided by NLM:


Further study details as provided by Northern California Retina Vitreous Associates:

Primary Outcome Measures:
  • BEST CORRECTED VISUAL ACUITY (ETDRS) [ Time Frame: AT DAY 180 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • RETINAL THICKNESS MEASURED BY SPECTRAL DOMAIN OPTICAL TOMOGRAPHY [ Time Frame: 90 and 180 DAYS ] [ Designated as safety issue: Yes ]
    CENTRAL FOVEAL THICKNESS AND MACULAR VOULUME


Enrollment: 6
Study Start Date: January 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Dexamethasone Implant
Patients will be treated with the Ozurdex (Dexamethasone Implant)
Drug: Dexamethasone Implant
Ozurdex (Dexamethasone Implant), 0.7 mg will injected intravitreally

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • DIABETIC PATIENTS WHO DEVELOP CYSTOID MACULA EDEMA AFTER CATARACT SURGERY (WITHIN 4-10 WEEKS AFTER SURGERY
  • VISUAL ACUITY WORSE THAN 20/32

Exclusion Criteria:

  • VISUAL ACUITY WORSE THAN 20/200
  • MODERATE OR SEVERE GLAUCOMA (AS DEFINED AS USING >2 TOPICAL GLAUCOMA MEDIATIONS.
  • USE OF SYSTEMIC, PERIOCULAR OR INTRAOCULAR CORTICOSTEROIDS WITHIN 30 DAYS OF ENROLLMENT
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01284478

Locations
United States, California
Northern California Retina Vitreous Associates
Mountain View, California, United States, 94040
Sponsors and Collaborators
Northern California Retina Vitreous Associates
Allergan
Investigators
Principal Investigator: Rahul Khurana, MD Northern California Retina Vitreous Associates
  More Information

No publications provided

Responsible Party: RAHUL KHURANA, M.D. / PRINCIPAL INVESTIGATOR, NORTHERN CALIFORNIA RETINA VITREOUS ASSOCIATES
ClinicalTrials.gov Identifier: NCT01284478     History of Changes
Other Study ID Numbers: NCRVA-2011-Ozurdex-16-1
Study First Received: January 25, 2011
Last Updated: October 3, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Northern California Retina Vitreous Associates:
pseudophakic cystoid macular edema, diabetic macular edema, Irvine Gass Syndrome, cataract surgery, ozurdex, dexamethasone

Additional relevant MeSH terms:
Capsule Opacification
Cataract
Edema
Macular Edema
Eye Diseases
Lens Diseases
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Signs and Symptoms
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors

ClinicalTrials.gov processed this record on October 29, 2014