An observational study to assess the profile of ranibizumab in patients with retinal vein occlusion in a real-world setting.

An observational, multi-center, open label study assessing the efficacy and safety of Lucentis (Ranibizumab intravitreal injections) in patients with visual impairment due to macular edema secondary to retinal vein occlusion (RVO)

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2015/07/005985

Enrollment

100

Registered

2015-07-08

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- Patients with visual impairment due to macular edema secondary to retinal vein occlusion (RVO)

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients willing to provide signed written informed consent. 2. Male and female aged 18 years and above. 3. Patients with macular edema due to BRVO and CRVO (confirmed by fundus photography, fluorescein angiography, OCT). 4. Baseline best-corrected visual acuity (BCVA) in the study eye from perception of light + (PL+) to 6/9 on Snellen chart

Exclusion criteria

Exclusion criteria: 1. Additional eye disease that could compromise VA 2. Active intraocular inflammation in either eye 3. Uncontrolled glaucoma in the study eye 4. Intraocular surgery 5. Any contra-indication according to local Summary of Product Characteristics or Prescribing Information (SmPC or PI) of ranibizumab

Design outcomes

Primary

Measure	Time frame
To evaluate the efficacy of ranibizumab 0.5 mg IVI in management of RVO in terms of mean change from baseline in Best Corrected Visual Acuity (BCVA) over a 48 week treatment period. Timepoint: over a 48 week treatment period treatment period.	—

Secondary

Measure	Time frame
To evaluate : 1)the mean change of Best corrected Visual acuity (BCVA) after injection of Ranibizumab 2)the change from baseline in central retinal thickness as measured by Optical Coherence Tomography (OCT) after 12 weeks, 24 weeks and 48 weeks. c)the progression of avascular area as measured by fluorescein angiography (FA) after 12 weeks, 24 weeks and 48 weeks. 4)the number of injections used for treatment. 5)other ocular and systemic safety issues.Timepoint: over a 48 week treatment period	—

Measure

Time frame

To evaluate : 1)the mean change of Best corrected Visual acuity (BCVA) after injection of Ranibizumab 2)the change from baseline in central retinal thickness as measured by Optical Coherence Tomography (OCT) after 12 weeks, 24 weeks and 48 weeks. c)the progression of avascular area as measured by fluorescein angiography (FA) after 12 weeks, 24 weeks and 48 weeks. 4)the number of injections used for treatment. 5)other ocular and systemic safety issues.Timepoint: over a 48 week treatment period

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Countries

India

Contacts

Public ContactDr Urmi Ahire

Novartis Healthcare Private Limited

urmi.ahire@novartis.com02224958400

Outcome results