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

Neovascular Glaucoma Clinical Trial

— LucNVG0108  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01370135
• Other study ID #: LucNVG0108
• Status: Completed
• Phase: N/A
• First received: May 27, 2011
• Last updated: January 15, 2013
• Start date: November 2008
• Est. completion date: July 2011

Study information

• Verified date: January 2013
• Source: University of Luebeck
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ethics Committee of the University of Lübeck: GermanyPaul-Ehrlich-Institut (PEI): Germany
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Neovascular
• Neovascular Glaucoma
• Rubeosis

Intervention

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

Locations

Country	Name	City	State
Germany	University of Lübeck - Department of Ophthalmology	Lübeck

Sponsors (1)

Lead Sponsor	Collaborator
University of Luebeck

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	changes in intraocular pressure	• to document changes in intraocular pressure measurements with the Goldmann applanation tonometer	12 Months	No
Secondary	changes in best corrected visual acuity (BCVA)	• to document changes in best corrected visual acuity (BCVA) measured on 4 meters	12 Months	No
Secondary	numbers of additional interventions	• to document numbers of additional interventions or anti-glaucomatous medications 12 months after injection	12 Months	No
Secondary	quality of life	• to document changes of quality of life	12 Months	No
Secondary	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	Yes
Secondary	changes in gonioscopy	• to document changes in gonioscopy of the anterior chamber angle	12 Months	No

External Links

•   University of Lübeck - Department of Ophthalmology - Germany