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

Study Overview
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Brief Summary
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Proliferative ischemic retinopathies lead to a formation of abnormal vessels on the iris surface induced by an increased level of vascular endothelial growth factor (VEGF). In progressive stages fibrovascular membranes occlude the anterior chamber angle which inhibits aqueous outflow resulting in neovascular glaucoma. The increased intraocular pressure is often difficult to control and frequently results in loss of vision. The aim of this study is to analyze the short- and long-term outcome after adjuvant intraocular Ranibizumab application in patients with neovascular glaucoma and rubeosis and to analyze the role of ranibizumab within a holistic treatment regime.

Official Title
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An Open Label, Prospective, Monocenter, Prove of Concept Study to Evaluate the Short- and Long-term Effects of 0.5mg Intraocular Ranibizumab (Lucentis) Injections as Adjuvant for Patients With Rubeosis and Neovascular Glaucoma

Conditions
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Neovascular Glaucoma, Rubeosis

Intervention / Treatment
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* Drug: 0.5mg intraocular Ranibizumab (Lucentis)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lucentis (Ranibizumab)<br> | Drug: 0.5mg intraocular Ranibizumab (Lucentis)<br>* short- and long-term effects of 0.5mg intraocular Ranibizumab (Lucentis) injections as adjuvant for patients with rubeosis and neovascular glaucoma<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of degree of iris rubeosis | 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. | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in intraocular pressure | • to document changes in intraocular pressure measurements with the Goldmann applanation tonometer | 12 Months | 
| changes in best corrected visual acuity (BCVA) | • to document changes in best corrected visual acuity (BCVA) measured on 4 meters | 12 Months | 
| numbers of additional interventions | • to document numbers of additional interventions or anti-glaucomatous medications 12 months after injection | 12 Months | 
| quality of life | • to document changes of quality of life | 12 Months | 
| Number of adverse events in all participants | • to evaluate the safety of intravitreal injections of ranibizumab (0.5 mg) as adjunctive in patients with rubeosis and neovascular glaucoma using the number of adverse events. | 12 Months | 
| changes in gonioscopy | • to document changes in gonioscopy of the anterior chamber angle | 12 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gonioscopy, short ans longterm effects, best corrected visual acuity, BCVA, neovascular glaucoma, rubeosis, anterior chamber, intraocular, intravitreal injections, Lucentis, Ranibizumab, quality of life