Ranibizumab for Branch Retinal Vein Occlusion Associated Macular Edema Study (RABAMES) (RABAMES)

July 20, 2011 updated by: Klinikum Ludwigshafen
The primary objective of this pilot study is to compare the functional and anatomic outcomes of chronic macular edema secondary to branch retinal vein occlusion (BRVO) treated with argon laser photocoagulation versus intravitreal ranibizumab (Lucentis®) injection versus a combination of both.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Freiburg, Germany
        • RABAMES investigational trial site
      • Göttingen, Germany
        • RABAMES investigational trial site
      • Ludwigshafen, Germany, 67063
        • RABAMES investigational trial site
      • Mainz, Germany
        • RABAMES investigational trial site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults aged 18 years and older with chronic (> 3months, < 18 months) macular edema secondary to branch retinal vein occlusion
  • Patients who at baseline have a BSCVA in the study eye between 20/320 and equivalent to 20/40, using an ETDRS chart measured at 4 meters
  • Patients who at baseline have a chronic macular edema (> 3 months) in the study eye with the following characteristics as determined by fluorescein angiography:
  • Evidence that the macular edema extends under the geometric center of the foveal avascular zone.
  • Evidence that the edema is only secondary to BRVO (no other relevant ocular diseases, e.g. uveitis).
  • Patients who at baseline have a chronic macular edema (> 3 months) in the study eye with the following characteristics as determined by optical coherence tomography (OCT 3):
  • Evidence that central macular thickness is > 225 μm.
  • Ability of subject to understand character and individual consequences of clinical trial.
  • Signed and dated informed consent of the subject must be available before start of any specific trial procedures.
  • For women with childbearing potential, adequate contraception (negative pregnancy test result, serum or urine at trial entry, after treatment and at end of study).
  • Only one eye of a patient may be included to this trial.

Exclusion Criteria:

  • Patients who at baseline
  • Have a relevant ocular disease which may be associated with increased intraocular VEGF levels (namely uveitis, neovascular glaucoma, neovascular age-related macular degeneration, diabetic retinopathy, diabetic maculopathy, ocular ischemic syndrome, and others)
  • Have a relevant systemic disease which may be associated with increased systemic VEGF levels (namely all malignancies)
  • Had previous treatment for macular edema (laser, triamcinolone, vitrectomy)
  • Pregnancy and lactation.
  • History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product.
  • Participation in other clinical trials within the last 3 months.
  • Medical or psychological condition that would not permit completion of the trial or signing of informed consent.
  • Arterial hypertension refractory to medical treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
laser photocoagulation to the retina at the area of edema
Procedure: Laser photocoagulation
laser photocoagulation to the retina at the area of edema
Experimental: 2
intravitreal injection of ranibizumab
Procedure: Laser photocoagulation
laser photocoagulation to the retina at the area of edema
Drug: Ranibizumab
intravitreal injection of 0.5 mg ranibizumab after randomisation, at week 4 and 8
Other Names:
  • Lucentis
Experimental: 3
laser photocoagulation to the retina at the area of edema and intravitreal injection of ranibizumab
Drug: Ranibizumab
intravitreal injection of 0.5 mg ranibizumab after randomisation, at week 4 and 8
Other Names:
  • Lucentis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in best spectacle-corrected visual acuity (BSCVA)
Time Frame: from baseline to month 6
from baseline to month 6

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean change in BSCVA
Time Frame: from baseline to month 3
from baseline to month 3
Proportion of patients who gain ≥ 5, 10, 15 letters of BSCVA
Time Frame: from baseline to month 3 and 6
from baseline to month 3 and 6
Proportion of patients who lose less than 15 letters of BCVA
Time Frame: from baseline to month 3 and 6
from baseline to month 3 and 6
Change in area and intensity of leakage
Time Frame: from baseline to month 1, 3 and 6
from baseline to month 1, 3 and 6
Mean change in central macular thickness (by OCT)
Time Frame: from baseline to month 1, 3 and 6
from baseline to month 1, 3 and 6
Mean change in central macular thickness (by OCT)
Time Frame: from month 3 to 6
from month 3 to 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Klinikum Ludwigshafen

Collaborators

Norvartis Pharma, Nuremberg, Germany
Coordination center for clinical studies, Mainz, Germany

Investigators

  • Principal Investigator: Lars-Olof Hattenbach, MD, Privatdozent, Dept. of Ophthalmology, Ludwigshafen hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

November 21, 2007

First Submitted That Met QC Criteria

November 21, 2007

First Posted (Estimate)

November 22, 2007

Study Record Updates

Last Update Posted (Estimate)

July 22, 2011

Last Update Submitted That Met QC Criteria

July 20, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AU-06104G

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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