Diabetic Macular Edema
Conditions
Interventions
Two groups:1.25mg intravitreal bevacizumab at monthly 3 months versus 2.5mg intravitreal bevacizumab
Sponsors
None listed
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Inclusion Criteria: 1. Aged 18 years or older; 2. Clinically significant macular edema (CSME) defined according to the ETDRS:- Retinal thickening at or within 500µm of the center of the macula; or - Hard exudates at or within 500µm of the center of the macula associated with adjacent retinal thickening; or - A zone or zones of retinal thickening of one disc area in size and at least part of which is within one disc diameter of the center of fovea; 3. Macular edema of at least 250µm involving the fovea, as documented on optical coherent tomography (OCT); 4. Patients with best-corrected visual acuity of better than 1.3 ETDRS logMAR units; 5. Patients physically fit to receive intravitreal injection; 6. Informed consent.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: 1. Ocular diseases other than cataract, CSME and refractive error, which includes: a. Any conditions known to cause macular edema, including retinal vein or artery occlusion, uveitis, premacular fibrosis, retinitis pigmentosa, macular hole and choroidal neovascularization; b. Fibrovascular proliferation with or without tractional retinal detachment; c. Glaucoma and ocular hypertension. 2. Proliferative diabetic retinopathy; 3. Media opacities which affect fundus examination or OCT measurements; 4. Previous intraocular surgery except uncomplicated cataract extraction and posterior intraocular lens insertion; 5. Any laser procedure within 4 months; or cataract extraction or intravitreal triamcinolone injection within 6 months; 6. Pregnant patients; 7. Failure to comply with follow up schedule; 8. Presence of a non-healing wound, ulcer, fracture, or any medical condition associated with bleeding; 9. "Single eye" patient with fellow eye having best-corrected visual acuity of 20/400 or worse; 10. History of fluorescein allergy; 11. Macular ischemia on fluorescein angiography.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Best-corrected visual acuity at 6 month; | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Retinal thickness measured by optical coherent tomography (OCT) at each visit;2. Proportion of patients with moderate visual loss at 6 months;3. Proportion of patients with stable or gain in vision at 6 months;4. Intraocular pressure measured by non-contact tonometry (NCT) at each visit;5. Changes in macular function as measured by multifocal electroretinography (mfERG) at each visit;6. Changes in fluorescein angiography at 6 months;7. Change in levels of aqueous VEGF, PEDF and other growth factors / cytokines during the study period; | — |
Countries
China
Contacts
Public ContactProf Dennis SC Lam
Outcome results
None listed