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Ranibizumab for Branch Retinal Vein Occlusion Associated Macular Edema Study (RABAMES)
This study is currently recruiting participants.
Study NCT00562406   Information provided by Klinikum Ludwigshafen
First Received: November 21, 2007   Last Updated: August 21, 2008   History of Changes
This Tabular View shows the required WHO registration data elements as marked by

November 21, 2007
August 21, 2008
November 2007
Changes in best spectacle-corrected visual acuity (BSCVA) [ Time Frame: from baseline to month 6 ]
Same as current
Complete list of historical versions of study NCT00562406 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
 
Ranibizumab for Branch Retinal Vein Occlusion Associated Macular Edema Study (RABAMES)
Ranibizumab for Branch Retinal Vein Occlusion Associated Macular Edema Study (RABAMES)

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.

 
 
Interventional
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Macular Edema
  • Drug: Ranibizumab
  • Procedure: Laser photocoagulation
  • Active Comparator: laser photocoagulation to the retina at the area of edema
  • Experimental: intravitreal injection of ranibizumab
  • Experimental: laser photocoagulation to the retina at the area of edema and intravitreal injection of ranibizumab
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
30
November 2008
 

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
Both
18 Years and older
No
Contact: Alireza Mirshahi, MD, FEBO +49 621 503 ext 3051 Mirshaha@klilu.de
Contact: Lars-Olof Hattenbach, MD +49 621 503 ext 3051 Hattebach.lo@klilu.de
Germany
 
 
NCT00562406
 
 
Klinikum Ludwigshafen
  • Norvartis Pharma, Nuremberg, Germany
  • Coordination center for clinical studies, Mainz, Germany
Principal Investigator: Lars-Olof Hattenbach, MD, Privatdozent Dept. of Ophthalmology, Ludwigshafen hospital
Klinikum Ludwigshafen
May 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.