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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Julia Lueke, University of Luebeck
ClinicalTrials.gov Identifier:
NCT01370135
First received: May 27, 2011
Last updated: January 15, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Neovascular Glaucoma
Rubeosis
Drug: 0.5mg intraocular Ranibizumab (Lucentis)

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

Resource links provided by NLM:


Further study details as provided by University of Luebeck:

Primary Outcome Measures:
  • change of degree of iris rubeosis [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • changes in intraocular pressure [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    • to document changes in intraocular pressure measurements with the Goldmann applanation tonometer

  • changes in best corrected visual acuity (BCVA) [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    • to document changes in best corrected visual acuity (BCVA) measured on 4 meters

  • numbers of additional interventions [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    • to document numbers of additional interventions or anti-glaucomatous medications 12 months after injection

  • quality of life [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    • to document changes of quality of life

  • Number of adverse events in all participants [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
    • 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.

  • changes in gonioscopy [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    • to document changes in gonioscopy of the anterior chamber angle


Enrollment: 20
Study Start Date: November 2008
Study Completion Date: July 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01370135

Locations
Germany
University of Lübeck - Department of Ophthalmology
Lübeck, Germany, 23538
Sponsors and Collaborators
University of Luebeck
Investigators
Principal Investigator: Salvatore Grisanti, M.D. Prof. University of Lübeck - Department of Ophthalmology: Germany
  More Information

No publications provided by University of Luebeck

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Julia Lueke, Dr. med. Julia Lüke, University of Luebeck
ClinicalTrials.gov Identifier: NCT01370135     History of Changes
Other Study ID Numbers: LucNVG0108
Study First Received: May 27, 2011
Last Updated: January 15, 2013
Health Authority: Ethics Committee of the University of Lübeck: Germany
Paul-Ehrlich-Institut (PEI): Germany

Keywords provided by University of Luebeck:
neovascular glaucoma
rubeosis
anterior chamber
intraocular
intravitreal injections
Lucentis
Ranibizumab
short ans longterm effects
best corrected visual acuity
gonioscopy
BCVA
quality of life

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Neovascular
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on April 15, 2014