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A study to know the predictability of treatment outcomes with OCT scan of the eye in patients undergoing injections of a class of drug known as anti-VEGFs for diabetic macular edema

The Role Of OCT-Based Biomarkers For Predicting Treatment Response In Eyes With Centre Involving Diabetic Macular Oedema Treated With Anti-VEGF Injections - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/09/073966
Enrollment
44
Registered
2024-09-17
Start date
Unknown
Completion date
Unknown
Last updated
2024-10-14

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: Anti-VEGF Injection: The study aims to investigate the association between SD-OCT Biomarkers and the treatment response among Diabetic Macular Oedema eyes treated with intravitreal Anti

Sponsors

Nethradhama Superspeciality Eye Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Pateints with either type 1 or type 2 Diabetes Mellitus aged 18 years or older, who have consented for the study. Centre-Involving Diabetic Macular Oedema (DMO), defined by sub-foveal involvement of abnormal intraretinal and/or subretinal fluid with concurrent thickening affecting the 1mm diameter of CST

Exclusion criteria

Exclusion criteria: 1. Pre-existing retinal or macular disease other than DR or DMO 2. SD-OCT images with porr quality 3. Pre-existing ocular diseases such as cataract, glaucoma, pathological myopia and uveitis 4. Any cataract surgery done in past 3 months 5. Prior vitreoretinal surgery or intravitreal anti-VEGF injections 6. Patients who have undergone any supplementary macular laser and / or intravitreal steroid implants

Design outcomes

Primary

MeasureTime frame
1. Morphology of DMO 2. Vitreomacular relationship 3. Presence of DRIL 4. Presence and number of hyperreflective retinal foci 5. Presence of hyper-reflectivity within intra-retinal cyst 6. Visibility and continuity of ELM or EZTimepoint: Taken before injection and at 1 month post injection

Secondary

MeasureTime frame
If there is any improvement in visual acuity of the patientTimepoint: Taken at 3 months & 6 months post injection

Countries

India

Contacts

Public ContactDr Mamatha N

Nethradhama Super Speciality Eye Hospital

mamtha.doc@gmail.com7795245633

Outcome results

None listed

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