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

This study has been completed.
Sponsor:
Collaborators:
Norvartis Pharma, Nuremberg, Germany
Coordination center for clinical studies, Mainz, Germany
Information provided by:
Klinikum Ludwigshafen
ClinicalTrials.gov Identifier:
NCT00562406
First received: November 21, 2007
Last updated: July 20, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention
Macular Edema
Drug: Ranibizumab
Procedure: Laser photocoagulation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ranibizumab for Branch Retinal Vein Occlusion Associated Macular Edema Study (RABAMES)

Resource links provided by NLM:


Further study details as provided by Klinikum Ludwigshafen:

Primary Outcome Measures:
  • Changes in best spectacle-corrected visual acuity (BSCVA) [ Time Frame: from baseline to month 6 ]

Secondary Outcome Measures:
  • Mean change in BSCVA [ Time Frame: 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 ]
  • Proportion of patients who lose less than 15 letters of BCVA [ Time Frame: from baseline to month 3 and 6 ]
  • Change in area and intensity of leakage [ Time Frame: 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 ]
  • Mean change in central macular thickness (by OCT) [ Time Frame: from month 3 to 6 ]

Enrollment: 30
Study Start Date: November 2007
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: Ranibizumab
intravitreal injection of 0.5 mg ranibizumab after randomisation, at week 4 and 8
Other Name: Lucentis
Procedure: Laser photocoagulation
laser photocoagulation to the retina at the area of edema
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 Name: Lucentis

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00562406

Locations
Germany
RABAMES investigational trial site
Freiburg, Germany
RABAMES investigational trial site
Göttingen, Germany
RABAMES investigational trial site
Ludwigshafen, Germany, 67063
RABAMES investigational trial site
Mainz, Germany
Sponsors and Collaborators
Klinikum Ludwigshafen
Norvartis Pharma, Nuremberg, Germany
Coordination center for clinical studies, Mainz, Germany
Investigators
Principal Investigator: Lars-Olof Hattenbach, MD, Privatdozent Dept. of Ophthalmology, Ludwigshafen hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00562406     History of Changes
Other Study ID Numbers: AU-06104G
Study First Received: November 21, 2007
Last Updated: July 20, 2011
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by Klinikum Ludwigshafen:
Macular edema secondary to branch retinal vein occlusion

Additional relevant MeSH terms:
Edema
Macular Edema
Retinal Vein Occlusion
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 22, 2014