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To Assess the Efficacy and Safety of Intravitreal Ranibizumab in People With Vision Loss Due to Macular Edema

NCT01846299 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 181

Last updated 2016-05-23

Study results available
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Summary

To evaluate the efficacy and safety of 0.5 mg Ranibizumab intravitreal injections in adult patients with visual impairment due to macular edema (ME).

Conditions

  • Macular Edema (ME)

Interventions

OTHER

Sham control

The sham vial did not contain active drug (empty sterile vial). The sham injection was an imitation of an intravitreal injection using an injection syringe without a needle touching the eye.

DRUG

Ranibizumab

Ranibizumab 0.5mg/0.5mL was administered intravitreally to the participant.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2015-09-30
Completion
2015-09-30

Countries

  • Australia
  • Belgium
  • Canada
  • Czechia
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Latvia
  • Netherlands
  • Russia
  • Singapore
  • Slovakia
  • South Korea
  • Spain
  • Switzerland
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01846299 on ClinicalTrials.gov