Ayurvedic treatment for diabetic macular edema

Phase 2

Conditions: Health Condition 1: H350- Background retinopathy and retinalvascular changes

Registration Number: CTRI/2023/05/053154

Lead Sponsor: Banaras Hindu University

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

At least one eye must meet all of the following criteria:

a)Patients age >=18 years of age, diagnosed with Type2 diabetes mellitus having decreased vision due to macular edema associated with non-proliferative diabetic retinopathy.

b)Diagnosis of diabetes mellitus (Type2)- Any one of the following will be considered to be sufficient evidence that diabetes is present:

•Current regular use of insulin for the treatment of diabetes

•Current regular use of oral anti-hyperglycaemic agents for the treatment of diabetes

•Documented diabetes by WHO guidelines

c)Best corrected ETDRS visual acuity score >=34 to 76 letters

d)Definite central retinal thickening of >=300 Î¼m due to diabetic macular edema detected by OCT examination.

e)Patients able and willing to provide informed consent.

f)No expectation that subject will be moving out of the area of the study centre during the next 6 months.

Exclusion Criteria

a)Patients of diabetic macular edema associated with Type1 diabetes mellitus and with Proliferative DR.

b)Conditions that would preclude participation in the study (e.g. unstable medical status including blood pressure and glycaemic control), patients with poor glycaemic control who recently initiated intensive treatment (a pump or multiple daily injections) or plan to do so in the next 6 months.

c)Patients treated with focal /grid laser within 6 month, intra-vitreal Anti-VEGF injections within 3 month and intra-vitreal steroid within 6 months of the study entry, history of intraocular surgery within 90 days before study entry.

d)Macula edema is not considered to be due to a cause other than diabetic macular edema. An eye should not be considered eligible

(1)If the macular edema is considered to be related to cataract extraction or

(2)Clinical exam and/or OCT suggests that vitreo-retinal interface disease (e.g. vitreo-retinal traction or epiretinal membrane) is the primary cause of macular edema.

e)Ocular condition (other than diabetes) that might affect macular edema or alter visual acuity (e.g. vein occlusion, uveitis or other ocular inflammatory diseases, neovascular glaucoma, Irvine-Gass Syndrome). Glaucoma per se is not an exclusion.

f)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 conditions).

g)Patients with a history of acute coronary events or stroke, renal failure, pregnancy, or lactation.

h)Media clarity, pupillary dilation, and patient cooperation insufficient for adequate fundus and OCT examination.

i)Active participation in any type of interventional study.

A patient may have both eyes eligible at the time of random allocation. In that case, the worse eye will be selected for the treatment, analysis and documentation purpose.