Status:
UNKNOWN
Triple Therapy for Diffuse Diabetic Macular Edema
Lead Sponsor:
Military Institute od Medicine National Research Institute
Conditions:
Diffuse Diabetic Macular Edema
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the safety end efficacy of combined phakoemulsification and vitrectomy with retinal endophotocoagulation and intraoperative use of bevacizumab in patients with...
Detailed Description
The pathogenesis of the diabetic macular edema is multiple. Therefore treatment of this disease should be combined too. VEGF is involved in pathogenesis of diabetic macular edema and recently anti-VEG...
Eligibility Criteria
Inclusion
- diagnosis of DDME on clinical exam, definite retinal thickening involving the center of the macula, confirmed by fluorescein angiography, with or without PVD,
- BCVA of 0,3 or worse in log MAR units (\<=70 ETDRS letter) and 1,5 or better in log MAR units (\>=10 ETRDS letter),
- mean central macular thickness greater than 250 μm on optic coherence tomography (OCT),
- presence of vitreomacular traction or a thickened and taut posterior hyaloid or presence of an epimacular membrane.
Exclusion
- significant macular ischemia defined as enlarged perifoveal capillary loss (\>1000 µm) by fluorescein angiography,
- the focal macular edema due to focal leakage from microaneurysm,
- ophthalmic disorders associated with macular edema, such as uveitis, branch or central retinal vein occlusion and pseudophakic cystoid macular edema,
- vitreous hemorrhage or tractional retinal detachment secondary to diabetic retinopathy,
- an ocular condition is present such that, visual acuity would not improve from resolution of macular edema (e.g., foveal atrophy, pigmentary abnormalities, dense subfoveal hard exudates),
- history of retinal macular photocoagulation, intravitreal corticosteroids, or other treatment for DME within 3 months prior to enrollment,
- history of any intraocular surgery within prior 6 months.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2011
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01218750
Start Date
December 1 2008
End Date
December 1 2011
Last Update
October 19 2010
Active Locations (1)
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1
Military Institute of Medicine
Warsaw, Szaserów 44, Poland, 04-141