Dexamethasone-implant for the Treatment of RVO

Ludwig Maximilian University of Munich

Status and phase: Completed; Phase 4

Conditions: Macular Edema Caused by Retinal Vein Occlusion

Treatments: Drug: Bevacizumab; Drug: Dexamethasone implant

Study type: Interventional

Funder types: Other

Identifiers

NCT01767545

Mayer-DEX-001

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

Dexamethasone-implant (Group 1)

Active Comparator group

Description:

Group 1 included 38 patients (22 with CRVO and 16 with BRVO) and was treated with a dexamethasone-implant injection from the beginning.

Treatment:

Drug: Dexamethasone implant

Bevacizumab/Dexamethasone-implant (Group 2)

Active Comparator group

Description:

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.

Treatment:

Drug: Bevacizumab

Drug: Dexamethasone implant