Ranibizumab for Branch Retinal Vein Occlusion Associated Macular Edema Study - RABAMES

• Conditions: Macular edema secondary to branch retinal vein occlusion; MedDRA version: 8.1Level: LLTClassification code 10025415Term: Macular oedema

• Registration Number: EUCTR2006-006131-53-DE
• Lead Sponsor: Society (institute) for clinical research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-02
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Adults aged 18 years and older with chronic (>3 months, <18 months) macular edema secondary to branch retinal vein occlusion
• Patients who at baseline have a best spectacle-corrected visual acuity (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:
o Evidence that the macular edema extends under the geometric center of the
foveal avascular zone.
o 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):
o 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)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Patients who at baseline
o 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)
o have a relevant systemic disease which may be associated with increased
systemic VEGF levels (namely all malignancies)
o 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: Safety of intravitreal ranibizumab injections will be studied further.;Primary end point(s): The changes in best spectacle-corrected visual acuity (BSCVA) from baseline to month 6 in patients treated with intravitreal ranibizumab alone versus laser group versus patients who received a combination of both treatment options.;Main Objective: This prospective randomized trial is designed 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. We intend to explore whether intravitreal ranibizumab alone or in combination with argon laser photocoagulation is equivalent or superior to laser photocoagulation alone for patients with chronic macular edema secondary to BRVO.