1. What data in particular will be shared?
   Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response - Informed Consent Form
   Response - Clinical Study Report
   Response -  Analytic Code
   
   
3. Who will be able to view these files?
   Response - Researchers who provide a methodologically sound proposal.
   


4. For what types of analyses will this data be available?
   Response - To achieve aims in the approved proposal.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [drmoharana@gmail.com].
   


6. For how long will this data be available start date provided 01-01-2026 and end date provided 31-12-2031?
   Response - Beginning 3 months and ending 5 years following article publication.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NIL

PRIMARY PURPOSE     

Diabetic retinopathy (DR) is a microvascular complication of diabetes mellitus (DM) that causes vision-threatening damage to the retina, resulting in visual impairment and blindness in the working-age population. Diabetic macular edema (DME) is the most common cause of moderate vision loss in DR. Currently, intravitreal injections of anti-VEGFs are considered the first-line therapy for DME. There is a requirement for multiple injections in an operation theatre setup, which disrupts the professional work, apart from causing a financial burden on the patient.

HCQ has been approved for the management of type 2 DM by the Drug Controller General of India (DCGI) at a dose of 400 mg/day as an adjunct to diet and exercise to improve glycemic control in patients on a combination of metformin and sulfonylureas. The drug was also endorsed by the Research Society for the Study of Diabetes in India (RSSDI) clinical practice recommendations as a third-line drug for managing type 2 DM. It has been proposed that due to its additional anti-inflammatory effect, oral HCQ may prove to be beneficial in DME. However, contradicting reports show no beneficial effect of HCQ on DR. These studies have been retrospective observational types. This study aims to prospectively investigate any beneficial or deleterious effect of HCQ on the DR.

STUDY HYPOTHESIS

HCQ has a beneficial effect on the macular thickness in patients with type 2 DM and DME.