Study to Evaluate the Effects of Ranibizumab (Lucentis) for Patients With Rubeosis and Neovascular Glaucoma (LucNVG0108)

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

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.

Study Overview

• Status: Completed
• Conditions: Neovascular Glaucoma; Rubeosis
• Intervention / Treatment: Drug: 0.5mg intraocular Ranibizumab (Lucentis)

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Lübeck, Germany, 23538
    • University of Lübeck - Department of Ophthalmology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Luebeck
• Investigators: Principal Investigator: Salvatore Grisanti, M.D. Prof., University of Lübeck - Department of Ophthalmology: Germany

Publications and helpful links

General Publications

• Luke J, Nassar K, Luke M, Grisanti S. Ranibizumab as adjuvant in the treatment of rubeosis iridis and neovascular glaucoma--results from a prospective interventional case series. Graefes Arch Clin Exp Ophthalmol. 2013 Oct;251(10):2403-13. doi: 10.1007/s00417-013-2428-y. Epub 2013 Jul 28.

Helpful Links

• University of Lübeck - Department of Ophthalmology - Germany

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: May 27, 2011
• First Submitted That Met QC Criteria: June 8, 2011
• First Posted (Estimate): June 9, 2011

Study Record Updates

• Last Update Posted (Estimate): January 16, 2013
• Last Update Submitted That Met QC Criteria: January 15, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: quality of life; Ranibizumab; Lucentis; BCVA; intravitreal injections; neovascular glaucoma; anterior chamber; intraocular; gonioscopy; rubeosis; short ans longterm effects; best corrected visual acuity
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Neovascular; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Ranibizumab
• Other Study ID Numbers: LucNVG0108