Rubeosis and Neovascular Glaucoma MedDRA version: 9.1 Level: LLT Classification code 10039291 Term: Rubeosis iridis MedDRA version: 9.1 Level: LLT Classification code 10062891 Term: Neovascular glaucoma
Conditions
Sponsors
Prof. Salvatore Grisanti
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. neo-vascular glaucoma or rubeosis 2. written informed consent 3. visual acuity of light perception or better. 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
Exclusion criteria: Systemic conditions or treatments 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 tachyarrythmias 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Main outcome measure is the change of degree of iris rubeosis as documented by iris fluorescein angiography as measured 12 months after the first ranibizumab injection. ;Secondary Objective: Secondary objectives are • to document changes in intraocular pressure measurements with the Goldmann applanation tonometer, • to document changes in best corrected visual acuity (BCVA) measured on 4 meters, • to document changes in gonioscopy of the anterior chamber angle and • to document numbers of additional interventions or anti-glaucomatous medications 12 months after injection. • to document changes of quality of life • to evaluate the safety of intravitreal injections of ranibizumab (0.5 mg) as adjunctive in patients with rubeosis and neovascular glaucoma ;Primary end point(s): Change of degree of iris rubeosis as documented by iris fluorescein angiography measured 12 months after the first ranibizumab injection. | — |
Countries
Germany
Outcome results
None listed