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

Launched by UNIVERSITY OF LUEBECK · Jun 8, 2011

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Eligibility criteria

• Inclusion Criteria:
• • 1. 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)
• • 2. an available follow-up of 12 months
• • 3. written informed consent
• • 4. visual acuity of light perception or better.
• Exclusion Criteria:
• • 1. history or evidence of severe cardiac disease (e.g., NYHA functional class III or IV)
• • 2. clinical or medical history of unstable angina, acute coronary syndrome, myocardial infarction or revascularization with 6 months
• • 3. ventricular tachyarrhythmias requiring ongoing treatment
• • 4. History or evidence clinically significant peripheral vascular disease, such as intermittent claudication or prior amputation
• • 5. Clinically significant impaired renal or hepatic function
• • 6. Stroke within 12 month before trial entry.
• • 7. Known serious allergies to the fluorescein dye use in angiography
• • 8. Known contraindications to the components of Lucentis® formulation.
• • Ocular concomitant conditions/ diseases
• • 1. Active intraocular inflammation (grade trace or above) in either eye
• • 2. Any active infection (e.g. conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis) in either eye
• • 3. History of uveitis in either eye
• • 4. Treatment with anti-angiogenic drugs (pegaptanib sodium, anecortave acetate,bevacizumab, ranibizumab, etc.) or intravitreal corticosteroids in either eye within 4 months prior to inclusion
• • 5. Angle block glaucoma
• • 6. Phthisis
• • 7. Intraocular Pressure \<10mmHg
• • Compliance/ Administrative
• • 1. 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
• • 2. 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.
• • 3. Pregnant or nursing (lactating) women
• • 4. Inability to comply with study or follow-up procedures.
• • 5. Any treatment with an investigational agent in the past 60 days for any condition.