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Diabetes and Eye

A 12-Month, open label, multi-center study to evaluate the efficacy and safety of intravitreal injections of Ranibizumab 0.5mg on cystoids, spongy and mixed Optical Coherence Tomography patterns secondary to Diabetic Macular Oedema (DME).

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2018/05/014060
Enrollment
30
Registered
2018-05-23
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

None listed

Interventions

Intervention1: Intravitreal Injection Lucentis (Ranibizumab Injection): 0.5mg (0.05ml) Single dose vial

Sponsors

Novartis Healthcare Pvt Ltd
Lead Sponsor
Giridhar Eye Institute
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Patients must be above 18 years of age having type 1 or type 2 diabetes mellitus. Decrease in vision specifically due to DME. Retinal thickness less than 300 micron and bilaterally fit cases.

Exclusion criteria

Exclusion criteria: Active intraocular inflammation, any active infection, history of uveitis, ocular disorders, epiretinal membrane, uncontrolled glaucoma, neovascularization of the iris, evidence of vitreomacular traction, active proliferative diabetic retinopathy.

Design outcomes

Primary

MeasureTime frame
Meanchange from baseline in BCVA assessed on early treatment diabetic retinopathy study (ETDRS) chart over a period of 48 weeks of Ranibizumab treatment in different morphological variants of Diabetic Macular Oedema.Timepoint: 12 Months—

Secondary

MeasureTime frame
Evaluate the mean change of BCVA on ETDRS after injection for 12 months on a monthly basis, evaluate the changes in intraretinal thickness and morphology in OCT; incidence and type of any clinical or lab adverse experiences.Timepoint: 12 Months—

Countries

India

Contacts

Public ContactDr Rameez N Hussain

Giridhar Eye Institute

dr.rameezhussain@gmail.com9444527891

Outcome results

None listed

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