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Dexamethasone-implant for the Treatment of RVO

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ClinicalTrials.gov Identifier: NCT01767545
Recruitment Status : Completed
First Posted : January 14, 2013
Last Update Posted : January 14, 2013
Sponsor:
Information provided by (Responsible Party):
Wolfgang Mayer, Ludwig-Maximilians - University of Munich

Brief Summary:
To evaluate the efficacy and safety of a dexamethasone-implant alone or in combination with bevacizumab. 64 eyes are prospectively investigated. Group 1 (22 CRVO and 16 BRVO) is treated with dexamethasone-implant alone, Group 2 (14 CRVO 12 BRVO) with three consecutive bevacizumab injections followed by a dexamethasone-implant. Recurrences are treated with dexamethasone-implant only. Patients are seen preoperatively and thereafter in monthly intervals. The primary endpoint was BCVA at twelve months.

Condition or disease Intervention/treatment Phase
Macular Edema Caused by Retinal Vein Occlusion Drug: Dexamethasone implant Drug: Bevacizumab Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Twelve Months Experience With a Dexamethasone-implant for the Treatment of Macular Edema Associated With Retinal Vein Occlusion
Study Start Date : September 2010
Actual Primary Completion Date : January 2011
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Dexamethasone-implant (Group 1)
Group 1 included 38 patients (22 with CRVO and 16 with BRVO) and was treated with a dexamethasone-implant injection from the beginning.
Drug: Dexamethasone implant
Active Comparator: Bevacizumab/Dexamethasone-implant (Group 2)
Group 2 included 26 patients (14 CRVO, 12 BRVO) and was treated with three consecutive injections of bevacizumab at a monthly interval, followed by a dexamethasone-implant injection four weeks after the last bevacizumab injection.
Drug: Dexamethasone implant Drug: Bevacizumab



Primary Outcome Measures :
  1. The primary clinical endpoint was BCVA twelve months after the first intravitreal treatment. [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Central retinal thickness [ Time Frame: 12 months ]
  2. Lens opacity [ Time Frame: 12 months ]
  3. Saftey of procedure [ Time Frame: 12 months ]


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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: maximum duration of symptoms of four months and no known history of glaucoma or corticosteroid response in the past -

Exclusion Criteria: Glaucoma, Diabetic Retinopathy, prior IVOM, Uveitis


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01767545


Locations
Germany
Dept. of Ophthalmology, LMU Munich
Munich, Germany, 80336
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich

Responsible Party: Wolfgang Mayer, MD, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier: NCT01767545     History of Changes
Other Study ID Numbers: Mayer-DEX-001
First Posted: January 14, 2013    Key Record Dates
Last Update Posted: January 14, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Macular Edema
Retinal Vein Occlusion
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Dexamethasone acetate
Dexamethasone
Bevacizumab
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors