Lucentis for New Onset Neovascular Glaucoma

NCT00727038 | Withdrawn Phase 1

• 2 other identifiers: 2007-0792FVF4143S
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Glaucoma; New Onset Glaucoma; Neovascular Glaucoma; New Onset Neovascular Glaucoma

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to Month 6.

Secondary Outcomes (12)

• Percent change in angle neovascularization (measured in clock hours by gonioscopy).

  Initial visit through Month 6

• Percent change in permanent angle closure (clock hours of peripheral anterior synechiae by gonioscopy).

  Initial visit through Month 6

• Mean change in intraocular pressure measured by applanation tonometry.

  Initial visit through Month 6

• Percent change in iris neovascularization (measured both in clock hours by slit lamp exam and with iris angiography).

  Initial visit through Month 6

• Rates of severe vision loss (visual acuity <20/200, loss of 6 lines or more on ETDRS chart).

  Initial Visit through Month 6

Study Arms (2)

1

EXPERIMENTAL

Lucentis (ranibizumab) with conventional treatment

Drug: Ranibizumab (Lucentis)

2

NO INTERVENTION

Conventional treatment

Interventions

Ranibizumab (Lucentis) DRUG

0.5 mg ranibizumab intravitreal injection single dose administration

Also known as: ranibizumab, Lucentis

1

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• Genentech, Inc.: collaborator

Related Publications (8)

• 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.

  PMID: 16508438 BACKGROUND

• Davidorf 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.

  PMID: 16508439 BACKGROUND

• Ferrara N. Vascular endothelial growth factor: basic science and clinical progress. Endocr Rev. 2004 Aug;25(4):581-611. doi: 10.1210/er.2003-0027.

  PMID: 15294883 BACKGROUND

• Fung 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.

  PMID: 16854824 BACKGROUND

• Iliev 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.

  PMID: 17157590 BACKGROUND

• Kahook MY, Schuman JS, Noecker RJ. Intravitreal bevacizumab in a patient with neovascular glaucoma. Ophthalmic Surg Lasers Imaging. 2006 Mar-Apr;37(2):144-6.

  PMID: 16583637 BACKGROUND

• Sivak-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.

  PMID: 11581047 BACKGROUND

• Results 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.

  PMID: 7487614 BACKGROUND

Related Links

• University of Illinois at Chicago Eye and Ear Infirmary homepage

MeSH Terms

Conditions

Glaucoma; Glaucoma, Neovascular; Retinal Vein Occlusion; Carotid Stenosis

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Retinal Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Michael P Blair, MD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Faculty Ophthalmology and Visual Services

Study Record Dates

• First Submitted: July 29, 2008
• First Posted: August 1, 2008
• Study Start: January 4, 2008
• Primary Completion: May 15, 2009
• Study Completion: May 15, 2009
• Last Updated: February 17, 2020

Record last verified: 2008-07