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

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