Dexamethasone-implant for the Treatment of RVO

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wolfgang Mayer, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT01767545
First received: January 9, 2013
Last updated: January 10, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Macular Edema Caused by Retinal Vein Occlusion
Drug: Dexamethasone implant
Drug: Bevacizumab
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Ludwig-Maximilians - University of Munich:

Primary Outcome Measures:
  • The primary clinical endpoint was BCVA twelve months after the first intravitreal treatment. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Central retinal thickness [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Lens opacity [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Saftey of procedure [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 64
Study Start Date: September 2010
Study Completion Date: February 2012
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
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

-

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01767545

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

No publications provided

Responsible Party: Wolfgang Mayer, MD, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier: NCT01767545     History of Changes
Other Study ID Numbers: Mayer-DEX-001
Study First Received: January 9, 2013
Last Updated: January 10, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Edema
Macular Edema
Retinal Vein Occlusion
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Bevacizumab
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 14, 2014