Study to Evaluate the Effects of Ranibizumab (Lucentis) for Patients With Rubeosis and Neovascular Glaucoma

Inclusion criteria

• neo-vascular glaucoma or rubeosis

• definition of neo-vascular glaucoma: patient with iris neovascularization with intraocular pressure elevation (exceeding 21 mmHg)
• definition of rubeosis: patient with iris neovascularization without intraocular pressure elevation (≤21 mmHg)
• an available follow-up of 12 months
• written informed consent
• visual acuity of light perception or better.

Exclusion criteria

• history or evidence of severe cardiac disease (e.g., NYHA functional class III or IV)
• clinical or medical history of unstable angina, acute coronary syndrome, myocardial infarction or revascularization with 6 months
• ventricular tachyarrhythmias requiring ongoing treatment
• History or evidence clinically significant peripheral vascular disease, such as intermittent claudication or prior amputation
• Clinically significant impaired renal or hepatic function
• Stroke within 12 month before trial entry.
• Known serious allergies to the fluorescein dye use in angiography
• Known contraindications to the components of Lucentis® formulation.

Ocular concomitant conditions/ diseases

• Active intraocular inflammation (grade trace or above) in either eye
• Any active infection (e.g. conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis) in either eye
• History of uveitis in either eye
• Treatment with anti-angiogenic drugs (pegaptanib sodium, anecortave acetate,bevacizumab, ranibizumab, etc.) or intravitreal corticosteroids in either eye within 4 months prior to inclusion
• Angle block glaucoma
• Phthisis
• Intraocular Pressure <10mmHg

Compliance/ Administrative

• Previous participation in any clinical studies of investigational drugs (excluding vitamins and minerals) within 1 month (or a period corresponding to 5 half-lives of the investigational drug, whatever is longer) prior to inclusion
• Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant. including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they are using two birth control methods. The two methods can be a double barrier method or a barrier method plus a hormonal method. Adequate barrier methods of contraception include: diaphragm, condom (by the partner), intrauterine device (copper or hormonal), sponge or spermicide. Hormonal contraceptives include any marketed contraceptive agent that includes an estrogen and/or a progestational agent.
• Pregnant or nursing (lactating) women
• Inability to comply with study or follow-up procedures.
• Any treatment with an investigational agent in the past 60 days for any condition.