Dexamethasone-implant for the Treatment of RVO

Sponsor

Ludwig-Maximilians - University of Munich (Other)

Overall Status

Completed

CT.gov ID

NCT01767545

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

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 :

Sep 1, 2010

Actual Primary Completion Date :

Jan 1, 2011

Actual Study Completion Date :

Feb 1, 2012

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

The primary clinical endpoint was BCVA twelve months after the first intravitreal treatment. [12 months]

Secondary Outcome Measures

Central retinal thickness [12 months]
Lens opacity [12 months]
Saftey of procedure [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Dept. of Ophthalmology, LMU Munich	Munich		Germany	80336

Sponsors and Collaborators

Ludwig-Maximilians - University of Munich

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Wolfgang Mayer, MD, Ludwig-Maximilians - University of Munich

ClinicalTrials.gov Identifier:

NCT01767545

Other Study ID Numbers:

Mayer-DEX-001

First Posted:

Jan 14, 2013

Last Update Posted:

Jan 14, 2013

Last Verified:

Jan 1, 2013

Additional relevant MeSH terms:

Macular Edema

Retinal Vein Occlusion

Dexamethasone

Bevacizumab

Study Results

No Results Posted as of Jan 14, 2013