Status:
COMPLETED
Effect of Ranibizumab on Malignant Conjunctival Neoplasia
Lead Sponsor:
The New York Eye Cancer Center
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Conjunctival Neoplasms
Eligibility:
All Genders
21+ years
Phase:
PHASE1
Brief Summary
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 ad...
Detailed Description
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 t...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00456495
Start Date
March 1 2007
End Date
September 1 2010
Last Update
July 21 2017
Active Locations (1)
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1
The New York Eye Cancer Center
New York, New York, United States, 10021