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

Recruitment Status
COMPLETED
(See Contacts and Locations)Verified December 2012 by University of Luebeck
Sponsor
University of Luebeck
Information Provided by (Responsible Party)
Dr. Julia Lueke
Clinicaltrials.gov Identifier
NCT01370135
Other Study ID Numbers:
LucNVG0108
First Submitted
May 26, 2011
First Posted
June 8, 2011
Last Update Posted
January 15, 2013
Last Verified
December 2012

ClinicalTrials.gov processed this data on January 2013. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Neovascular GlaucomaRubeosis
Drug: 0.5mg intraocular Ranibizumab (Lucentis)

Study Design

Study TypeInterventional
Actual Enrollment20 participants
Design AllocationNon-Randomized
Interventional ModelSingle Group Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleAn 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
Study Start DateOctober 31, 2008
Actual Primary Completion DateMarch 31, 2011
Actual Study Completion DateJune 30, 2011

Groups and Cohorts

Group/CohortIntervention/Treatment
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

Outcome Measures

Primary Outcome Measures
  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.
Secondary Outcome Measures
  1. changes in intraocular pressure
    • to document changes in intraocular pressure measurements with the Goldmann applanation tonometer
  2. changes in best corrected visual acuity (BCVA)
    • to document changes in best corrected visual acuity (BCVA) measured on 4 meters
  3. numbers of additional interventions
    • to document numbers of additional interventions or anti-glaucomatous medications 12 months after injection
  4. quality of life
    • to document changes of quality of life
  5. 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.
  6. changes in gonioscopy
    • to document changes in gonioscopy of the anterior chamber angle

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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

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