Ayurvedic drug trial on Diabetic Retinopathy

Phase 2

• Conditions: Health Condition 1: H358- Other specified retinal disorders

• Registration Number: CTRI/2024/03/064454
• Lead Sponsor: one

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 1 April 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean change in Central Subfield Thickness (CST) <br/ ><br>Timepoint: 3 months.

Secondary Outcome Measures

Name	Time	Method
Mean change in best corrected viaual acuity (BCVA) <br/ ><br>Mean change in Central Retinal Thickness (CRT) and Maximum Macular Thickness (MMT)Timepoint: 3 months.