CTRI/2020/04/024637
Other
未知
Efficacy and Safety of Hydroxychloroquine Sulfate in Type 2 Diabetes Patients withNon-proliferative Diabetic Retinopathy (NPDR)
IPGMER and SSKM Hospital0 sites0 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Health Condition 1: E113- Type 2 diabetes mellitus with ophthalmic complications
- Sponsor
- IPGMER and SSKM Hospital
- Status
- Other
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Male and female patients aged between \>\=18 and \<\=65 years
- •2\. Type 2 diabetes with HbA1c between \>\=7% and \<\=10\.5%, despite receiving stable dose of metformin \+ sulfonylurea with or without other OHAs (excluding DPP\-IV inhibitors and hydroxychloroquine) for at least 12 weeks.
- •3\. Mild to severe NPDR (DRSS levels score \>\= 20 and \<\= 53\) in whom PRP (panretinal photocoagulation) can be safely deferred for at least 6 months as per the investigator/opthalmologist.
- •4\. Best corrected visual acuity\-early treatment diabetic retinopathy study (BCVA ETDRS) letter score in the study eye of \>\=65 letters \[approximate Snellen equivalent of \>\=0\.4 (20/50\)]
- •5\. Central foveal thickness (CFT) \<\= 275 µm of retina by OCT
- •6\. Patients with body weight \>\= 60 Kg
- •7\. Patients able to understand and willing to fully comply with study procedures and restrictions
- •8\. Patient ready to give informed consent to participate in the study, in accordance with the International Conference for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), Good Clinical Practice (GCP) Guidelines, before completing any study related procedures
Exclusion Criteria
- •1\. Uncontrolled hyperglycemia i.e FPG \>240 mg/dL
- •2\. Patients with Type 1 diabetes
- •3\. Presence of diabetic macular edema (DME) threatening the center of the macula in the study eye
- •4\. Evidence of retinal neovascularization on clinical examination
- •5\. Any prior focal or grid laser photocoagulation, prior panretinal photocoagulation (PRP) or refractive surgery in the study eye
- •6\. Any prior systemic anti\-VEGF treatment or prior intraocular steroid injection in the study eye within 3 months from enrollment.
- •7\. Current anterior segment neovascularization (ASNV), vitreous hemorrhage, or tractional retinal detachment diagnosed by SD\-OCT and color and red\-free fundus photography, visible at the screening assessments in the study eye.
- •8\. Concomitant retinal disease due to causes other than diabetic microangiopathy.
- •9\. Patients with recent glaucoma and cataract surgery
- •10\. Patients with dilatation of the pupil \<5 mm
Outcomes
Primary Outcomes
Not specified
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