Clinical trial NCT00456495: Effect of Ranibizumab on Malignant Conjunctival Neoplasia
Official title: Effect of Ranibizumab on Malignant Conjunctival Neoplasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Conjunctival Neoplasms
Lead sponsor: The New York Eye Cancer Center
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2007-04-05
Enrollment: 5
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

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 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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Number of Patients Assessed for Safety and Tolerability
timeFrame: 2 years
Secondary outcomes:
measure: Evaluating Tumor Destruction or Reduction
timeFrame: 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: The New York Eye Cancer Center
state: New York
Study officials:
affiliation: The New York Eye Cancer Center
name: Paul T. Finger, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Finger PT, Chin KJ. Refractory squamous cell carcinoma of the conjunctiva treated with subconjunctival ranibizumab (Lucentis): a two-year study. Ophthalmic Plast Reconstr Surg. 2012 Mar-Apr;28(2):85-9. doi: 10.1097/IOP.0b013e3182392f29.