Effect of Ranibizumab on Malignant Conjunctival Neoplasia
Completed · Phase 1
Conditions studied: Conjunctival Neoplasms
In brief
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.
Key facts
- Study ID
- NCT00456495
- Run by
- The New York Eye Cancer Center
- People needed
- 5
- Starts
- 2007-03-01
- Expected to finish
- 2010-09-01
- Last updated by the study team
- 2017-07-21
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: not accepted.
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
- 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
You may not qualify if…
- 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
Where it is running
- The New York Eye Cancer Center — New York, New York, United States
Full record on ClinicalTrials.gov
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