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Study Detail: DRCRnet Vitrectomy
Trial Description
Summary
: This is a study to collect data to assess the potential benefits and risks of vitrectomy for the treatment of Diabetic Macular Edema. The results may then be used to determine whether proceeding with a randomized trial has merit and what the design of the trial should be.
Basic Trial Information
|
Phase |
Disease |
Status |
Age |
Sponsor |
Protocol # |
|
Prospective |
Diabetic macular edema |
Enrolling |
> 18 |
DRCRnet |
NA |
Study Duration: Three (3) years
Eligibility Criteria:
Inclusion Criteria
·
Type 1 or Type 2 diabetic·
Patient ability to have fundus photos taken·
Presence of VMT associated with macular edema OR edema too diffuse to respond to focal or grid laser OR edema inadequately responsive to previous treatments & unlikely to benefit from further focal photocoagulation·
PPVX surgical treatment being performed as treatment for DME·
Please check with clinical coordinator for other inclusion criteriaExclusion Criteria
·
Macular edema due to other causes than diabetes·
Other ocular conditions present hat would not improve from resolution of macular edema or that might affect macular edema or alter visual acuity·
History of retinal macular photocoagulation, intravitreal corticosteroids or other treatment for DME within 3.5 months prior to enrollment·
History of peripheral scatter photocoagulation within 4 months prior to enrollment·
History of PPVX·
History of other major ocular surgery within 6 months prior to, or anticipated 6 months after enrollment·
History of YAG capsulotomy performed within 2 months prior to enrollment·
Please check with clinical coordinator for other exclusion criteria
Study Title: Evaluation of Vitrectomy for Diabetic Macular Edema Study
Trial Contact Information
|
Site |
Study Coordinator |
|
Beachwood Lakewood |
Trina 216/831-5704 ext. 6800 |


