Clinical trial NCT01370135: Study to Evaluate the Effects of Ranibizumab (Lucentis) for Patients With Rubeosis and Neovascular Glaucoma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University of Luebeck
Sponsor class: OTHER
First posted: 2011-06-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: change of degree of iris rubeosis
timeFrame: 12 Months
Secondary outcomes:
measure: changes in intraocular pressure
timeFrame: 12 Months
measure: changes in best corrected visual acuity (BCVA)
timeFrame: 12 Months
measure: numbers of additional interventions
timeFrame: 12 Months
measure: quality of life
timeFrame: 12 Months
measure: Number of adverse events in all participants
timeFrame: 12 Months
measure: changes in gonioscopy
timeFrame: 12 Months
Other outcomes:
Locations:
city: Lübeck
country: Germany
facility: University of Lübeck - Department of Ophthalmology
Study officials:
affiliation: University of Lübeck - Department of Ophthalmology: Germany
name: Salvatore Grisanti, M.D. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.