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

NCT01370135 | Completed DMC

• 1 other identifier: LucNVG0108
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neovascular Glaucoma; Rubeosis

Keywords

neovascular glaucoma; rubeosis; anterior chamber; intraocular; intravitreal injections; Lucentis; Ranibizumab; short ans longterm effects; best corrected visual acuity; gonioscopy; BCVA; quality of life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• changes in intraocular pressure

  12 Months

• changes in best corrected visual acuity (BCVA)

  12 Months

• numbers of additional interventions

  12 Months

• quality of life

  12 Months

• Number of adverse events in all participants

  12 Months

Study Arms (1)

Lucentis (Ranibizumab)

EXPERIMENTAL

Drug: 0.5mg intraocular Ranibizumab (Lucentis)

Interventions

0.5mg intraocular Ranibizumab (Lucentis) DRUG

short- and long-term effects of 0.5mg intraocular Ranibizumab (Lucentis) injections as adjuvant for patients with rubeosis and neovascular glaucoma

Lucentis (Ranibizumab)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Angle block glaucoma
• Phthisis
• Intraocular Pressure \<10mmHg

Sponsors & Collaborators

• University of Luebeck: lead

Study Sites (1)

University of Lübeck - Department of Ophthalmology

Lübeck, 23538, Germany

Location

Related Publications (1)

• 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.

  PMID: 23893090 DERIVED

Related Links

• University of Lübeck - Department of Ophthalmology - Germany

MeSH Terms

Conditions

Glaucoma, Neovascular

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Salvatore Grisanti, M.D. Prof.

  University of Lübeck - Department of Ophthalmology: Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med. Julia Lüke

Study Record Dates

• First Submitted: May 27, 2011
• First Posted: June 9, 2011
• Study Start: November 1, 2008
• Primary Completion: April 1, 2011
• Study Completion: July 1, 2011
• Last Updated: January 16, 2013

Record last verified: 2013-01

Locations

DE (1)