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Effect of intravitreal drugs on integrity of retinal layers

Evaluation of outer retinal layers after Intravitreal AntiVEGF Therapy in Diabetic Macular Edema - ORLBT

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/03/018135
Enrollment
88
Registered
2019-03-18
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

Health Condition 1: H350- Background retinopathy and retinalvascular changes

Interventions

Intervention1: INTRAVITREAL BEVACIZUMAB : dosage of 1.25 mg/0.05 ml,frequency of 3 injections in 6 months,Intravitreal route of administration,6 months total duration of therapy Control Intervention1:

Sponsors

Department of Ophthalmology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. All consecutive cases of Type 2 DM, between age group 40-65 years, attending Retina Clinic of Department of Ophthalmology, K.G.M.U., Lucknow 2. In asymmetrical involvement, the eye with more severe form of the disease will be included

Exclusion criteria

Exclusion criteria: 1.Patients with any other ocular or systemic disease which can affect the retinal vasculature( Ischemic heart disease) 2. Previous intravitreal injection(s), ophthalmic surgical or laser interventions

Design outcomes

Primary

MeasureTime frame
Restoration Of Outer And Inner Retinal Layers Following Intravitreal Bevacizumab AdministrationTimepoint: 6 months

Secondary

MeasureTime frame
Restoration Of Outer ,Inner Retinal Layers And Ellipsoid Zone Following Intravitreal BevacizumabTimepoint: 6 MONTHS

Countries

India

Contacts

Public ContactSandeep Saxena

King Georges medical University Lucknow

sandeepsaxena2020@yahoo.com9415160528

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 26, 2026