Neovascular GlaucomaLucNVG0108NCT01370135
Study to Evaluate the Effects of Ranibizumab (Lucentis) for Patients With Rubeosis and Neovascular Glaucoma
A study testing 0.5mg intraocular Ranibizumab (Lucentis) in people with Neovascular Glaucoma and Rubeosis, run by University of Luebeck at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neovascular Glaucoma, Rubeosis
- What is being tested?
- 0.5mg intraocular Ranibizumab (Lucentis)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2008to Jul 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
- Treatment with anti-angiogenic drugs (pegaptanib sodium, anecortave acetate,bevacizumab, ranibizumab, etc.) or intravitreal corticosteroids in either eye within 4 months prior to inclusion
- Angle block glaucoma
- Phthisis
- Intraocular Pressure <10mmHg
- Compliance/ Administrative
- 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
- 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.
- Pregnant or nursing (lactating) women
- Inability to comply with study or follow-up procedures.
- Any treatment with an investigational agent in the past 60 days for any condition.
Trial locations and contacts
1 site in 1 country.
Germany1 site
University of Lübeck - Department of Ophthalmology
Lübeck, 23538
About this study
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
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
- Being tested
- 0.5mg intraocular Ranibizumab (Lucentis)
- Keywords
- neovascular glaucoma, rubeosis, anterior chamber, intraocular, intravitreal injections, Lucentis, Ranibizumab, short ans longterm effects, best corrected visual acuity, gonioscopy, BCVA, quality of life
- Medical subject headings
- Glaucoma, Neovascular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Lucentis (Ranibizumab) | Experimental | Not described Receives: Drug: 0.5mg intraocular Ranibizumab (Lucentis) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 Months
Secondary outcomes (6)
changes in intraocular pressure
- to document changes in intraocular pressure measurements with the Goldmann applanation tonometer
Measured: 12 Months
changes in best corrected visual acuity (BCVA)
- to document changes in best corrected visual acuity (BCVA) measured on 4 meters
Measured: 12 Months
numbers of additional interventions
- to document numbers of additional interventions or anti-glaucomatous medications 12 months after injection
Measured: 12 Months
quality of life
- to document changes of quality of life
Measured: 12 Months
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.
Measured: 12 Months
changes in gonioscopy
- to document changes in gonioscopy of the anterior chamber angle
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2011 (estimated)
- Study startNov 2008
- Primary completionApr 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neovascular GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Luebeck
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Julia Lueke, University of Luebeck
- Investigators
- Salvatore Grisanti, M.D. Prof., Principal investigator, University of Lübeck - Department of Ophthalmology: Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01370135
- Sponsor's protocol ID
- LucNVG0108
- Acronym
- LucNVG0108
- Status last verified
- Jan 2013
- First submitted
- 27 May 2011
- Last updated
- 16 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23893090
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01370135
- Acronym / sponsor ID
- LucNVG0108 / LucNVG0108
- Conditions
- Neovascular Glaucoma, Rubeosis
- Keywords
- neovascular glaucoma, rubeosis, anterior chamber, intraocular, intravitreal injections, Lucentis, Ranibizumab, short ans longterm effects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of LuebeckUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Apr 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 9 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lucentis (Ranibizumab) | Experimental | Drug: 0.5mg intraocular Ranibizumab (Lucentis) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- neo-vascular glaucoma or rubeosis
- an available follow-up of 12 months
- written informed consent
- visual acuity of light perception or better.
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | Lucentis (Ranibizumab) |
Primary outcome
change of degree of iris rubeosis
Time frame: 12 Months
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.
6 secondary outcomes
changes in intraocular pressure
Time frame: 12 Months
changes in best corrected visual acuity (BCVA)
Time frame: 12 Months
numbers of additional interventions
Time frame: 12 Months
quality of life
Time frame: 12 Months
Number of adverse events in all participants
Time frame: 12 Months
changes in gonioscopy
Time frame: 12 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2013.
- Derived from this study: PubMed 23893090Luke 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.
- University of Lübeck - Department of Ophthalmology - GermanyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salvatore Grisanti, M.D. Prof. principal investigator
University of Lübeck - Department of Ophthalmology: Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 0.5mg intraocular Ranibizumab (Lucentis) in people with Neovascular Glaucoma and Rubeosis, run by University of Luebeck at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of degree of iris rubeosis (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01370135, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2013.