The Effect of Intravitreal Ozurdex on DME After Cataract Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01748487|
Recruitment Status : Completed
First Posted : December 12, 2012
Last Update Posted : December 2, 2015
The purpose of this study is to assess the efficacy and safety of OZURDEX (dexamethasone intravitreal implant) 0.7 mg administered immediately after phacoemulsification and intraocular lens implantation in type 1 or 2 diabetic patients to prevent the occurrence of post-surgical macular edema (ME).
Treatment group: 24 patients will receive an intravitreal injection of OZURDEX at the end of cataract surgery Patients will be seen at 1 week pre-operatively (baseline visit), and on the same day post-surgery (visit 1), at 1 week (visit 2), 1 month (visit 3) and 3 months (visit 4).
BCVA, IOP and SD-OCT will be performed at each visit.
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Macular Edema||Drug: dexamethasone intravitreal implant (OZURDEX)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of the Effect of Intravitreal Dexamethasone Implant (700 Micrograms) on Diabetic Macular Edema After Cataract Surgery|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||September 2015|
24 patients will receive an intravitreal injection of OZURDEX at the end of cataract surgery.
Drug: dexamethasone intravitreal implant (OZURDEX)
Other Name: OZURDEX
- The primary outcome measure will be the change from baseline for the central retinal thickness (CRT) measured by OCT at 3 months after surgery. [ Time Frame: 3 months ]
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): NCT01748487
|UHN, Toronto Western Hospital|
|Toronto, Ontario, Canada, M5T2S8|
|Principal Investigator:||Michael H Brent, MD||UHN_Toronto Western Hospital|