Dexamethasone Intravitreal Implant for Treatment of Macular Edema After Plaque Radiotherapy of Uveal Melanoma

PHASE2TerminatedINTERVENTIONAL
Enrollment

6

Participants

Timeline

Start Date

April 30, 2014

Primary Completion Date

July 31, 2015

Study Completion Date

July 31, 2015

Conditions
Macular EdemaCystoid Macular EdemaUveal MelanomaRadiation MaculopathyRadiation Retinopathy
Interventions
DRUG

Ozurdex

"Eyes in the Ozurdex group can have a maximum total of three Ozurdex insertions in the first 12 months after enrolling into the study. The criteria for retreatment with Ozurdex are:~i.The study eye must have shown initial favorable response to prior Ozurdex implant (\>10% decrease in central macular thickness with maintenance \[change in BCVA of \<=1 line\] or improvement of visual acuity \[increase of BCVA of \>1 line\]) ii. Interval since last Ozurdex implant should be \> 4 and \< 12 months. iii. The study eye must show definite evidence of recurrence of macular edema."

DRUG

Bevacizumab

Eyes in the Bevacizumab group can have a maximum total of twelve bevacizumab injections in the first year after enrolling into the study. All patients will receive 6 monthly injections after entering the study. After the sixth injection (at month 5) the interval between injections will be extended to 6 weeks if the study eye has shown initial favorable response to prior intravitreal bevacizumab.

Trial Locations (1)

19107

Ocular Oncology Service, Wills Eye Institute, Philadelphia

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Allergan

INDUSTRY

lead

Arman Mashayekhi

OTHER