Effect of oral (tablets) hydroxycholoroquine on the retinal edema (fluid accumulation) in patients suffering from diabetes mellitus and diabetic retinopathy.

Effect of oral hydroxychloroquine on the macular thickness in patients of non-proliferative diabetic retinopathy with clinically significant macular edema. - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/09/073741

Enrollment

Registered

2024-09-10

Start date

Unknown

Completion date

Unknown

Last updated

2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E113- Type 2 diabetes mellitus with ophthalmic complications

Interventions

Intervention1: Hydroxychloroquine: Oral hydroxychloroquine 400mg once daily as an add-on anti-diabetic drug. Control Intervention1: Routine anti-diabetic drugs like Metformin, sulphonylureas, DPP-4 in

Eligibility

Inclusion criteria

Inclusion criteria: 1.Type 2 diabetes mellitus 2.Moderate to very severe non-proliferative diabetic retinopathy with clinically significant macular edema 3.HbA1C: 7.0-8.5% 4.Hb: more than or equal to 9g/dl 5.On oral antidiabetic drug

Exclusion criteria

Exclusion criteria: 1.Patients on pioglitazone 2.Uncontrolled hypertension 3.Chronic kidney disease stage 3 and above 4.Cardiac diseases 5.Deranged liver function 6.Patients on tamoxifen citrate 7.Patients with deranged lipid profile (serum triglyceride more than 400mg/dl) 8.Significant media opacity that does not allow adequate fundus evaluation. 9.Patients with proliferative diabetic retinopathy 10.Patients requiring antivascular endothelial growth factor injection or have received the same within the last 3 months. 11.Patients on insulin 12.Pathological myopia 13.Ocular trauma 14.Any other coexisting retinochoroidal disease or history of vitreoretinal surgery

Design outcomes

Primary

Measure	Time frame
Change in macular thickness.Timepoint: 3 months	—

Secondary

Measure	Time frame
Change in best-corrected visual acuityTimepoint: 3 months, 6 months;Change in macular thicknessTimepoint: 6 months;Progression of the grade of DR.Timepoint: 3 months, 6 months;Retinal toxicity secondary to hydroxychloroquine (HCQ).Timepoint: 6 months	—

Countries

India

Contacts

Public ContactDr Bruttendu Moharana

All India Institute of Medical Sciences, Bhubaneswar

achantasrilasya@gmail.com8985359324

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026