Effect of Ranibizumab on Malignant Conjunctival Neoplasia
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|ClinicalTrials.gov Identifier: NCT00456495|
Recruitment Status : Completed
First Posted : April 5, 2007
Results First Posted : June 6, 2013
Last Update Posted : July 21, 2017
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The purpose of this study is to test the safety and tolerability of subconjunctival injection of ranibizumab in the treatment of malignant conjunctival neoplasia using the incidence and severity of adverse events.
Our secondary objective is to assess the efficacy of ranibizumab treatment on malignant conjunctival neoplasia by evaluating tumor destruction or reduction as documented by slit-lamp photography and ultrasonographic imaging and the regression of blood vessels.
|Condition or disease||Intervention/treatment||Phase|
|Conjunctival Neoplasms||Drug: ranibizumab||Phase 1|
Ranibizumab is a recently approved vascular endothelial growth factor (VEGF) inhibitor shown to be effective in treating exudative macular degeneration. Its analog, Avastin has also been employed to treat macular edema, proliferative diabetic retinopathy and wet age related macular degeneration. Ranibizumab binds to and inhibits vascular endothelial growth factor A (VEGF-A), which has been shown to cause neovascularization and leakage in models of ocular angiogenesis. Binding to VEGF-A prevents ranibizumab's interaction with VEGFR-1 and -2 receptors on the surface of endothelial cells, thereby reducing proliferation, vascular leakage, and angiogenesis.
Given that conjunctival tumors require the formation of new blood vessels to supply the proliferating cells, we propose a study to evaluate the effect of subconjunctival ranibizumab as a primary intervention in patients with conjunctival tumors.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Ranibizumab on Malignant Conjunctival Neoplasia|
|Study Start Date :||March 2007|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||September 2010|
Experimental: Subconjunctival ranibizumab
Patients will receive subconjunctival ranibizumab every 2-4 weeks.
Subconjunctival injection of drug every 2 to 4 weeks
Other Name: Lucentis
- Number of Patients Assessed for Safety and Tolerability [ Time Frame: 2 years ]To test the safety and tolerability of subconjunctival injection of ranibizumab in the treatment of malignant conjunctival neoplasia - using comparative slit lamp examination [anterior segment and ocular adnexal examination for adverse events (eg abrasion, melting), visual acuity (number of patients with decrease in visual acuity), and blood pressure at each visit (number of patients with increased blood pressure from baseline), and monthly urinalyis (number of patients with abnormal protein level in urine).
- Evaluating Tumor Destruction or Reduction [ Time Frame: 2 years ]To evaluate the efficacy of treatment using comparative slit lamp examinations (anterior segment and ocular adnexal exam) to evaluate tumor volume, from baseline to month 12, and 24. To report on the number of patients with improvement in tumor volume.
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|Ages Eligible for Study:||21 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
- Age > 21 years
- Tumors whose treatment with standard therapy would cause significant visual morbidity
- Diagnosis of biopsy proven malignant conjunctival neoplasia and are
- Recurrent disease
- Multi-focal disease
- Diffuse disease
- Extension of tumor into eye or orbit.
- Regional spread or metastatic disease
- Pregnancy (positive pregnancy test) or lactation.
- Premenopausal 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.
- Current infection or inflammation in either eye
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00456495
|United States, New York|
|The New York Eye Cancer Center|
|New York, New York, United States, 10021|
|Principal Investigator:||Paul T. Finger, MD||The New York Eye Cancer Center|
|Responsible Party:||Paul T. Finger, MD, Principal Investigator, The New York Eye Cancer Center|
|Other Study ID Numbers:||
|First Posted:||April 5, 2007 Key Record Dates|
|Results First Posted:||June 6, 2013|
|Last Update Posted:||July 21, 2017|
|Last Verified:||June 2017|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
Neoplasms by Site
Angiogenesis Modulating Agents
Physiological Effects of Drugs