E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Rubeosis and Neovascular Glaucoma |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10039291 |
E.1.2 | Term | Rubeosis iridis |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10062891 |
E.1.2 | Term | Neovascular glaucoma |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. neo-vascular glaucoma or rubeosis 2. written informed consent 3. visual acuity of light perception or better.
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | Primary end point(s) |
Change of degree of iris rubeosis as documented by iris fluorescein angiography measured 12 months after the first ranibizumab injection. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | Information not present in EudraCT |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |