A observational study to evaluate the efficacy and safety of Ranibizumab in patients with visual impairment due to Diabetic Macular Edema(DME

A multi-center, open-label, observational study to evaluate the efficacy and safety of intravitreal injections (IVI) of Ranibizumab in patients with visual impairment due to Diabetic Macular Edema (DME) - UNVEIL- DME

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2015/06/005945

Enrollment

300

Registered

2015-06-24

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 Diabetic Macular Edema

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients willing to provide signed, written informed consent 2.Patients with macular edema due to Diabetes (confirmed by fundus photography, fluorescein angiography, OCT) 3.Male and female aged 18 and above. 4.Vision Impairment due to DME (PL + to 6/9 on Snellen chart).

Exclusion criteria

Exclusion criteria: 1. Concomitant conditions in the study eye which could, in the opinion of the investigator, prevent the improvement of visual acuity on study treatment. 2. Active intraocular inflammation in either eye. 3. Uncontrolled glaucoma in the study eye. 4. Active proliferative diabetic retinopathy in the study eye. 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 efficacy of ranibizumab 0.5 mg in management of DME in terms of mean change from baseline in BCVA over a 48 week treatment period.Timepoint: over a 48 week treatment period	—

Secondary

Measure	Time frame
1) To evaluate the mean change of Best corrected Visual acuity after injection of Ranibizumab 0.5 mg 2) To evaluate the change in intraretinal thickness in Optical Coherence Tomography (OCT) after 12 weeks, 24 weeks & 48 weeks 3) To evaluate the progression of avascular area by fluorescein angiography (FA) after 12 weeks, 24 weeks & 48 weeks. 4) To evaluate the number of injections for treatment. 5) To evaluate other ocular & systemic safety issues. Timepoint: over a 48 week treatment period	—

Measure

Time frame

1) To evaluate the mean change of Best corrected Visual acuity after injection of Ranibizumab 0.5 mg 2) To evaluate the change in intraretinal thickness in Optical Coherence Tomography (OCT) after 12 weeks, 24 weeks & 48 weeks 3) To evaluate the progression of avascular area by fluorescein angiography (FA) after 12 weeks, 24 weeks & 48 weeks. 4) To evaluate the number of injections for treatment. 5) To evaluate other ocular & 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.com022-24958400

Outcome results