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A study to find the effectivity of single injection of the drug Razumab in improving vision in the affected eye .This study will help the patients with diabetic eye problems by improving their vision and reducing the number of hospital visits.

A prospective interventional study to find the effectivity of Razumab by measuring macular edema pre and post intravitreal injection.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/05/042804
Enrollment
76
Registered
2022-05-25
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-01

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

Conditions

Health Condition 1: H00-H59- Diseases of the eye and adnexa

Interventions

Intervention1: Intravitreal Razumab: Razumab is an intravitreal antivascular endothelial growth factor injected intravitreally for reducing macular edema. 0.5mg of Razumab in 0.05ml will be injected i

Sponsors

ESIC postgraduate institute of medical science and research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: patients with diabetic macular edema or macular edema due to retinal vaso-occlussive disease with central macular thickness of less or equal to 315 micron and visual acuity of less or equal to 0.2 on LogMAR chart will be included in the study.

Exclusion criteria

Exclusion criteria: 1. pre existing macular scar or dystrophy. 2.patients with active inflammatory and infectious diseases of the eye. 3. Patients already under treatment for macular edema in other hospital. 4.patients with history of recent ocular history or trauma. 5. patients with history of cerebrovascular or cardiovascular comorbidities.

Design outcomes

Primary

MeasureTime frame
1.the percentage of reduction of macular edema after 4 weeks. Timepoint: 1.the percentage of reduction of macular edema after 4 weeks.

Secondary

MeasureTime frame
improvement in best corrected visual acuity after 4 weeks of injection of intravitreal RazumabTimepoint: 1.visual acuity and macular edema will be measured before the intravitreal antivegf injection. 2. 1 week later, intraocular pressure is measured to rule out side effects. 3. 1 month after the injection, visual acuity and macular edema will be re- assessed.

Countries

India

Contacts

Public ContactMalathi VK

ESIC postgraduate institute of medical science and research

guru.ukm@gmail.com9444418536

Outcome results

None listed

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