Health Condition 1: H358- Other specified retinal disorders
Conditions
Interventions
None listed
Sponsors
None
Eligibility
Inclusion criteria
Inclusion criteria: Patient who consent for study Study eye having CI-DME as confirmed on OCT. Patients with best corrected ETDRS visual acuity score of at least 79 (Snellen equivalent of 20/25). Patients who decline both intravitreous therapy and laser photocoagulation and willing to take study group medication. Patients with good glycemic control by diet control, lifestyle modifications or systemic hypoglycemic drugs. Only one eye of participant to be included. The eye with worse BCVA will be included in the study. In case both eyes have equal best corrected visual acuity the right eye will be considered for study. Non-pregnant women.
Exclusion criteria
Exclusion criteria: Patient with diabetic macular edema with proliferative diabetic retinopathy Patients treated with focal/grid laser within 6 month, intravitreal Anti-VEGF injections within 3 month and intravitreal steroid within 6 months of study entry, history of intraocular surgery within 90 days before study entry. Patients with unstable medical status including blood pressure and glycemic control Patients in poor glycemic control who recently initiated intensive insulin treatment (a pump or multiple daily injections) or plan to do so in the next 6 months. Macular edema is not considered to be due to a cause other than diabetic macular edema. An eye should not be considered eligible (i) if the macular edema is considered to be related to cataract extraction or (ii) clinical examination and/or OCT suggests that vitreoretinal interface disease (e.g. vitreo-retinal traction or epiretinal membrane) is the primary cause of the macular edema. Ocular condition (other than diabetes) that might affect macular edema or alter visual acuity (e.g. vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, Irvine- Gass Syndrome). Glaucoma per se is not an exclusion. An ocular condition is present such that, visual acuity would not improve from resolution of macular edema (e.g. foveal atrophy, pigmentary changes, dense sub-foveal hard exudates, non- retinal condition). Patients with a history of acute coronary event or stroke, renal failure, pregnancy or lactation. Media clarity, pupillary dilation, and patient cooperation insufficient for adequate fundus and OCT examination. If patient decides to leave the trial to undergo intravitreous standard therapy. Any adverse effect observed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in Central Subfield Thickness (CST) Timepoint: 3 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in best corrected viaual acuity (BCVA) Mean change in Central Retinal Thickness (CRT) and Maximum Macular Thickness (MMT)Timepoint: 3 months. | — |
Countries
India
Contacts
Public ContactVijina Ravindran
Banaras Hindu University
Outcome results
None listed