GlaucomaPhase 1/2NVGNCT00727038
Lucentis for New Onset Neovascular Glaucoma
A Phase 1/2 study testing Ranibizumab (Lucentis) in people with Glaucoma and New Onset Glaucoma, run by University of Illinois at Chicago.
Trial summary
Neovascular glaucoma is a potentially debilitating disease of the eye. Vascular eye disease such as diabetes and vein occlusions can cause the retina to release factors that promote the growth of abnormal blood vessels. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Glaucoma, New Onset Glaucoma, Neovascular Glaucoma
- What is being tested?
- Ranibizumab (Lucentis)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 4 Jan 2008to 15 May 2009
- Phase
- Phase 1/2
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
- Age > 21 years
- Diagnosis of neovascular glaucoma (angle neovascularization with or without iris neovascularization and IOP > 21 mm Hg and > 5 mm Hg IOP compared to the fellow eye).
- Neovascular glaucoma secondary to retinal ischemia (central retinal vein occlusion, proliferative diabetic retinopathy, ocular ischemic syndrome, etc.)
Who cannot join
- Pregnancy (positive pregnancy test) or lactation or pre-menopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.
- Prior enrollment in the study
- Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
- Participation in another simultaneous medical investigation or trial
- > 270 degrees of closed trabecular meshwork (closure secondary to peripheral anterior synechiae)
- History of active inflammatory, infectious, or idiopathic keratitis precluding view of the anterior segment structures.
- Previous intravitreal injections of ranibizumab or bevacizumab in either eye.
About this study
Official title: Randomized Controlled Trial of Lucentis in the Management of New Onset Neovascular Glaucoma
Neovascular glaucoma is a potentially debilitating disease of the eye. Vascular eye disease such as diabetes and vein occlusions can cause the retina to release factors that promote the growth of abnormal blood vessels. These abnormal vessels can grow in the drainage mechanism of the eye causing pressure in the eye to markedly increase. This can potentially cause irreversible damage to the optic nerve from glaucoma leading to permanent blindness and painful eyes. Conventional treatments including laser and freezing therapy take weeks to cause regression in abnormal blood vessel growth. This delay often results in permanent vision loss and pain. New medications targeted at more immediately reducing blood vessel growth may aid in the treatment of this disease.
Read the detailed description
Hypothesis:
Intravitreal injection of Lucentis prior to conventional treatment for neovascular glaucoma improves overall outcome compared to conventional treatment alone.
Specific Aims:
To determine if pre-treatment with a single intravitreal injection of Lucentis prior to conventional treatment prevents severe vision loss and improves intraocular pressure control compared to conventional treatment alone.
Neovascular glaucoma is a potentially devastating consequence of fibrovascular proliferation of the anterior chamber angle with subsequent obstruction of the trabecular meshwork. The production of peripheral anterior synechiae along the trabecular meshwork leads to progressive angle closure. The subsequent elevation in intraocular pressure is difficult to manage, often leading to rapid progression of glaucoma and significant loss of vision. Enucleation for blind, painful eyes secondary to neovascular glaucoma is not an uncommon sequelae.
Neovascular glaucoma has many etiologic causes, the vast majority resulting from retinal ischemia secondary to relatively common diseases such as central retinal vein occlusion, proliferative diabetic retinopathy and ocular ischemic syndrome (carotid stenosis). (Sivac-Callcott et al., 2001) Vascular endothelial growth factor is likely a major contributor to the development of angle and iris neovascularization. (Ferrara, 2004) Although panretinal photocoagulation and/or cryoablation are mainstays of conventional treatment for neovascular glaucoma, the delayed therapeutic effect of these interventions often results in the formation of peripheral anterior synechiae and permanent angle closure.
Recent limited case series have demonstrated a role for bevacizumab (Avastin) in reducing rubeosis iridis and as an adjunct for neovascular glaucoma. (Grisanti et al., 2006; Davidorf et al., 2006; Iliev et al., 2006; Kahook, Schuman, Noecker, 2006) However, no prospective studies have examined the potential utility of anti-vascular endothelial growth factor agents in the treatment of neovascular glaucoma. Intravitreal Lucentis is the standard of care for the treatment of exudative macular degeneration. Pharmacologic agents such as Lucentis, which selectively inhibit vascular endothelial growth factor may provide an important therapeutic adjunct for the treatment of neovascular glaucoma by more immediately causing regression of angle neovascularization and thereby providing a window for permanent treatment with laser or cryotherapy.
- Being tested
- Ranibizumab (Lucentis)
- Keywords
- glaucoma, neovascular glaucoma, new onset glaucoma, retinal ischemia, central retinal vein occlusion, proliferative diabetic retinopathy, ocular ischemic syndrome, carotid stenosis, vascular endothelial growth factor, neovascular
- Medical subject headings
- Glaucoma, Glaucoma, Neovascular, Retinal Vein Occlusion, Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ranibizumab (Lucentis)Drug
Also called ranibizumab, Lucentis
0.5 mg ranibizumab intravitreal injection single dose administration
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Lucentis (ranibizumab) with conventional treatment Receives: Drug: Ranibizumab (Lucentis) |
| 2 | No intervention | Conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in best corrected visual acuity (BCVA) as assessed by the number of letters read correctly on the ETDRS eye chart at a starting test distance of 4 meters from baseline to Month 6.
Measured: Baseline to Month 6.
Secondary outcomes (12)
Percent change in angle neovascularization (measured in clock hours by gonioscopy).
Measured: Initial visit through Month 6
Percent change in permanent angle closure (clock hours of peripheral anterior synechiae by gonioscopy).
Measured: Initial visit through Month 6
Mean change in intraocular pressure measured by applanation tonometry.
Measured: Initial visit through Month 6
Percent change in iris neovascularization (measured both in clock hours by slit lamp exam and with iris angiography).
Measured: Initial visit through Month 6
Rates of severe vision loss (visual acuity <20/200, loss of 6 lines or more on ETDRS chart).
Measured: Initial Visit through Month 6
Number of intraocular pressure lowering medications needed to control intraocular pressure.
Measured: Initial Visit through Month 6
Mean change in optic nerve cupping.
Measured: Initial Visit through Month 6
Percent of patients requiring surgical glaucoma procedure to control intraocular pressure (trabeculectomy, seton, or ciliary body destruction).
Measured: Study duration
Percent of patients requiring pars plana vitrectomy with endolaser.
Measured: Study duration
Rates of endophthalmitis.
Measured: Study duration
Rates of rhegmatogenous retinal detachment.
Measured: Study duration
Final clock hours of permanent angle closure (clock hours of peripheral anterior synechiae by gonioscopy)
Measured: Month 6 visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2008 (estimated)
- Study start4 Jan 2008
- Primary completion15 May 2009
- Study completion15 May 2009
Why it stopped: Company withdrew funding/sponsorship
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Principal investigator, Michael Blair, University of Illinois at Chicago
- Investigators
- Michael P Blair, MD, Principal investigator, University of Illinois at Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00727038
- Sponsor's protocol ID
- 2007-0792
- Other IDs
- FVF4143S
- Acronym
- NVG
- Status last verified
- Jul 2008
- First submitted
- 29 Jul 2008
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Avery RL. Regression of retinal and iris neovascularization after intravitreal bevacizumab (Avastin) treatment. Retina. 2006 Mar;26(3):352-4. doi: 10.1097/00006982-200603000-00016. No abstract available.
PubMed 16508438Davidorf FH, Mouser JG, Derick RJ. Rapid improvement of rubeosis iridis from a single bevacizumab (Avastin) injection. Retina. 2006 Mar;26(3):354-6. doi: 10.1097/00006982-200603000-00017. No abstract available.
PubMed 16508439Ferrara N. Vascular endothelial growth factor: basic science and clinical progress. Endocr Rev. 2004 Aug;25(4):581-611. doi: 10.1210/er.2003-0027.
PubMed 15294883Fung AE, Rosenfeld PJ, Reichel E. The International Intravitreal Bevacizumab Safety Survey: using the internet to assess drug safety worldwide. Br J Ophthalmol. 2006 Nov;90(11):1344-9. doi: 10.1136/bjo.2006.099598. Epub 2006 Jul 19.
PubMed 16854824Iliev ME, Domig D, Wolf-Schnurrbursch U, Wolf S, Sarra GM. Intravitreal bevacizumab (Avastin) in the treatment of neovascular glaucoma. Am J Ophthalmol. 2006 Dec;142(6):1054-6. doi: 10.1016/j.ajo.2006.06.066. Epub 2006 Aug 2.
PubMed 17157590Kahook MY, Schuman JS, Noecker RJ. Intravitreal bevacizumab in a patient with neovascular glaucoma. Ophthalmic Surg Lasers Imaging. 2006 Mar-Apr;37(2):144-6.
PubMed 16583637Sivak-Callcott JA, O'Day DM, Gass JD, Tsai JC. Evidence-based recommendations for the diagnosis and treatment of neovascular glaucoma. Ophthalmology. 2001 Oct;108(10):1767-76; quiz1777, 1800. doi: 10.1016/s0161-6420(01)00775-8.
PubMed 11581047Results of the Endophthalmitis Vitrectomy Study. A randomized trial of immediate vitrectomy and of intravenous antibiotics for the treatment of postoperative bacterial endophthalmitis. Endophthalmitis Vitrectomy Study Group. Arch Ophthalmol. 1995 Dec;113(12):1479-96.
PubMed 7487614
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Lucentis in the Management of New Onset Neovascular Glaucoma
- ClinicalTrials.gov ID
- NCT00727038
- Acronym / sponsor ID
- NVG / 2007-0792
- Keywords
- glaucoma, neovascular glaucoma, new onset glaucoma, retinal ischemia, central retinal vein occlusion, proliferative diabetic retinopathy, ocular ischemic syndrome, carotid stenosis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Company withdrew funding/sponsorship
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Illinois at ChicagoUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- 4 Jan 2008 (actual)
- Primary completion
- 15 May 2009 (actual)
- Study completion
- 15 May 2009 (actual)
- First posted
- 1 Aug 2008 (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.
Neovascular glaucoma is a potentially debilitating disease of the eye. Vascular eye disease such as diabetes and vein occlusions can cause the retina to release factors that promote the growth of abnormal blood vessels. These abnormal vessels can grow in the drainage mechanism of the eye causing pressure in the eye to markedly increase. This can potentially cause irreversible damage to the optic nerve from glaucoma leading to permanent blindness and painful eyes. Conventional treatments including laser and freezing therapy take weeks to cause regression in abnormal blood vessel growth. This delay often results in permanent vision loss and pain. New medications targeted at more immediately reducing blood vessel growth may aid in the treatment of this disease.
Detailed description
Hypothesis:
Intravitreal injection of Lucentis prior to conventional treatment for neovascular glaucoma improves overall outcome compared to conventional treatment alone.
Specific Aims:
To determine if pre-treatment with a single intravitreal injection of Lucentis prior to conventional treatment prevents severe vision loss and improves intraocular pressure control compared to conventional treatment alone.
Neovascular glaucoma is a potentially devastating consequence of fibrovascular proliferation of the anterior chamber angle with subsequent obstruction of the trabecular meshwork. The production of peripheral anterior synechiae along the trabecular meshwork leads to progressive angle closure. The subsequent elevation in intraocular pressure is difficult to manage, often leading to rapid progression of glaucoma and significant loss of vision. Enucleation for blind, painful eyes secondary to neovascular glaucoma is not an uncommon sequelae.
Neovascular glaucoma has many etiologic causes, the vast majority resulting from retinal ischemia secondary to relatively common diseases such as central retinal vein occlusion, proliferative diabetic retinopathy and ocular ischemic syndrome (carotid stenosis). (Sivac-Callcott et al., 2001) Vascular endothelial growth factor is likely a major contributor to the development of angle and iris neovascularization. (Ferrara, 2004) Although panretinal photocoagulation and/or cryoablation are mainstays of conventional treatment for neovascular glaucoma, the delayed therapeutic effect of these interventions often results in the formation of peripheral anterior synechiae and permanent angle closure.
Recent limited case series have demonstrated a role for bevacizumab (Avastin) in reducing rubeosis iridis and as an adjunct for neovascular glaucoma. (Grisanti et al., 2006; Davidorf et al., 2006; Iliev et al., 2006; Kahook, Schuman, Noecker, 2006) However, no prospective studies have examined the potential utility of anti-vascular endothelial growth factor agents in the treatment of neovascular glaucoma. Intravitreal Lucentis is the standard of care for the treatment of exudative macular degeneration. Pharmacologic agents such as Lucentis, which selectively inhibit vascular endothelial growth factor may provide an important therapeutic adjunct for the treatment of neovascular glaucoma by more immediately causing regression of angle neovascularization and thereby providing a window for permanent treatment with laser or cryotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Ranibizumab (Lucentis)Lucentis (ranibizumab) with conventional treatment |
| 2 | No intervention | –Conventional treatment |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
- Age > 21 years
- Diagnosis of neovascular glaucoma (angle neovascularization with or without iris neovascularization and IOP > 21 mm Hg and > 5 mm Hg IOP compared to the fellow eye).
- Neovascular glaucoma secondary to retinal ischemia (central retinal vein occlusion, proliferative diabetic retinopathy, ocular ischemic syndrome, etc.)
Key exclusion criteria (7 listed)
- Pregnancy (positive pregnancy test) or lactation or pre-menopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.
- Prior enrollment in the study
- Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
- Participation in another simultaneous medical investigation or trial
- > 270 degrees of closed trabecular meshwork (closure secondary to peripheral anterior synechiae)
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 |
|---|---|---|
| Ranibizumab (Lucentis)Also: ranibizumab, Lucentis0.5 mg ranibizumab intravitreal injection single dose administration | Drug | 1 |
Primary outcome
Mean change in best corrected visual acuity (BCVA) as assessed by the number of letters read correctly on the ETDRS eye chart at a starting test distance of 4 meters from baseline to Month 6.
Time frame: Baseline to Month 6.
12 secondary outcomes
Percent change in angle neovascularization (measured in clock hours by gonioscopy).
Time frame: Initial visit through Month 6
Percent change in permanent angle closure (clock hours of peripheral anterior synechiae by gonioscopy).
Time frame: Initial visit through Month 6
Mean change in intraocular pressure measured by applanation tonometry.
Time frame: Initial visit through Month 6
Percent change in iris neovascularization (measured both in clock hours by slit lamp exam and with iris angiography).
Time frame: Initial visit through Month 6
Rates of severe vision loss (visual acuity <20/200, loss of 6 lines or more on ETDRS chart).
Time frame: Initial Visit through Month 6
Number of intraocular pressure lowering medications needed to control intraocular pressure.
Time frame: Initial Visit through Month 6
Mean change in optic nerve cupping.
Time frame: Initial Visit through Month 6
Percent of patients requiring surgical glaucoma procedure to control intraocular pressure (trabeculectomy, seton, or ciliary body destruction).
Time frame: Study duration
Percent of patients requiring pars plana vitrectomy with endolaser.
Time frame: Study duration
Rates of endophthalmitis.
Time frame: Study duration
Rates of rhegmatogenous retinal detachment.
Time frame: Study duration
Final clock hours of permanent angle closure (clock hours of peripheral anterior synechiae by gonioscopy)
Time frame: Month 6 visit
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- Background: PubMed 16508438Avery RL. Regression of retinal and iris neovascularization after intravitreal bevacizumab (Avastin) treatment. Retina. 2006 Mar;26(3):352-4. doi: 10.1097/00006982-200603000-00016. No abstract available.
- Background: PubMed 16508439Davidorf FH, Mouser JG, Derick RJ. Rapid improvement of rubeosis iridis from a single bevacizumab (Avastin) injection. Retina. 2006 Mar;26(3):354-6. doi: 10.1097/00006982-200603000-00017. No abstract available.
- Background: PubMed 15294883Ferrara N. Vascular endothelial growth factor: basic science and clinical progress. Endocr Rev. 2004 Aug;25(4):581-611. doi: 10.1210/er.2003-0027.
- Background: PubMed 16854824Fung AE, Rosenfeld PJ, Reichel E. The International Intravitreal Bevacizumab Safety Survey: using the internet to assess drug safety worldwide. Br J Ophthalmol. 2006 Nov;90(11):1344-9. doi: 10.1136/bjo.2006.099598. Epub 2006 Jul 19.
- Background: PubMed 17157590Iliev ME, Domig D, Wolf-Schnurrbursch U, Wolf S, Sarra GM. Intravitreal bevacizumab (Avastin) in the treatment of neovascular glaucoma. Am J Ophthalmol. 2006 Dec;142(6):1054-6. doi: 10.1016/j.ajo.2006.06.066. Epub 2006 Aug 2.
- Background: PubMed 16583637Kahook MY, Schuman JS, Noecker RJ. Intravitreal bevacizumab in a patient with neovascular glaucoma. Ophthalmic Surg Lasers Imaging. 2006 Mar-Apr;37(2):144-6.
- Background: PubMed 11581047Sivak-Callcott JA, O'Day DM, Gass JD, Tsai JC. Evidence-based recommendations for the diagnosis and treatment of neovascular glaucoma. Ophthalmology. 2001 Oct;108(10):1767-76; quiz1777, 1800. doi: 10.1016/s0161-6420(01)00775-8.
- Background: PubMed 7487614Results of the Endophthalmitis Vitrectomy Study. A randomized trial of immediate vitrectomy and of intravenous antibiotics for the treatment of postoperative bacterial endophthalmitis. Endophthalmitis Vitrectomy Study Group. Arch Ophthalmol. 1995 Dec;113(12):1479-96.
- University of Illinois at Chicago Eye and Ear Infirmary homepageLink 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.
Michael P Blair, MD principal investigator
University of Illinois at Chicago
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ranibizumab (Lucentis) in people with Glaucoma and New Onset Glaucoma, run by University of Illinois at Chicago.
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 4 inclusion and 7 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: withdrawn, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Mean change in best corrected visual acuity (BCVA) as assessed by the number of letters read correctly on the ETDRS eye chart at a starting test distance of 4 meters from baseline to Month 6. (time frame: Baseline to Month 6.). 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 NCT00727038, which also lists 8 linked publications.
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 17 Feb 2020.