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This study assessing the efficacy and safety of Ozurdex implant alone Vs Ozurdex implant plus Laser in patient with impairment of vision due to ophthalmic illness (Macular Edema follow by Branch Retinal Vein Occlusion).

An Exploratory, Randomized study assessing the efficacy and safety of Ozurdex implant alone Vs Ozurdex implant plus Laser in patient with visual impairment due to Macular Edema Secondary to Branch Retinal Vein Occlusion (BRVO).

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2014/03/004508
Enrollment
40
Registered
2014-03-27
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: null- Branch Retinal Vein Occlusion (BRVO)

Interventions

Intervention1: Ozurdex Impant: In one arm, Patient with Macular Edema and Branch Retinal Vein Occlusion will get Ozurdex Implant only in study eye Control Intervention1: Ozurdex implant plus Laser: I

Sponsors

Allergan India Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Fluorescein proven perfused macular edema involving the foveal center 2.Vision reduced to 3.On OCT macular thickness greater than 250 micron 4. BRVO less than 90 days 5.Willing to give informed consent

Exclusion criteria

Exclusion criteria: 1.Media opacities which can interfere with the investigative modalities ad visualization 2.Uncontrolled/advanced glaucoma 3.Active/suspected viral infections of eye 4.Diabetic retinopathy 5.Patient unwilling to give consent 6.One eyed patient

Design outcomes

Primary

MeasureTime frame
To assess the efficacy by evaluating mean change from baseline in best corrected visual acuity (BCVA) and intraretinal thickness changes in Optical Coherence tomography (OCT).Timepoint: 12 Months—

Secondary

MeasureTime frame
Evaluation of tolerability and safety, intraocular pressure (IOP) and lens changes (cataract).Timepoint: 12 Months—

Countries

India

Contacts

Public Contactkapil gupta

Dr Rajendra Prasad Centre for Ophthalmic Sciences

rajvardhanazad@hotmail.com

Outcome results

None listed

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