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Efficacy Study of Ranibizumab on Patients With Age-related Macular Degeneration.

NCT01831947 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2013-04-15

No results posted yet for this study

Summary

This clinical trial investigates the impact of intravitreal injection of Ranibizumab antibody on the acuteness of vision. Patients included are suffering from choroidal neo-vascularization (CNV) as a consequence of age-related macular degeneration (AMD).

Initially, all patients get injections of 0.5 mg Ranibizumab in monthly intervals for 3 months. Subsequently, one group gets Ranibizumab in intervals of 2 months, whereas a second group is treated on demand.

The primary end point of the study is the change of best-corrected visual acuity after 12 month.

Secondary end points include the impact of Ranibizumab on morphological changes of the retina, the number of patients with gain or loss of 15 or more letters visual acuity after 12 months, changes in quality of life and the number of injections required during the first 12 months of treatment.

Conditions

  • Macular Degeneration

Interventions

BIOLOGICAL

Ranibizumab

Sponsors & Collaborators

  • Novartis Pharmaceuticals

    collaborator INDUSTRY

  • University Medical Center Goettingen

    collaborator OTHER

  • Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • Germany

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 NCT01831947 on ClinicalTrials.gov