Conjunctival Neoplasms
Conditions
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.
Interventions
DRUGranibizumab
Subconjunctival injection of drug every 2 to 4 weeks
Sponsors
Genentech, Inc.
The New York Eye Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Assessed for Safety and Tolerability | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluating Tumor Destruction or Reduction | 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. |
Countries
United States
Participant flow
Recruitment details
Five consecutive subjects were enrolled over an 18-month period in a single ophthalmic oncology center.
Pre-assignment details
There was a single ARM in this study. Subconjunctival 0.5 mg ranibizumab was given as intervention every 2-4 weeks.
Participants by arm
| Arm | Count |
|---|---|
| Squamous Carcinoma of Conjunctiva Subconjunctival 0.5 mg ranibizumab | 5 |
| Total | 5 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 2 |
Baseline characteristics
| Characteristic | Squamous Carcinoma of Conjunctiva |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Age, Continuous | 53 years STANDARD_DEVIATION 11 |
| Region of Enrollment United States | 5 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
Number of Patients Assessed for Safety and Tolerability
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).
Time frame: 2 years
Population: Analysis was per protocol. Treatment was delivered every 2-4 weeks with good safety and tolerability
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Open Label Treatment | Number of Patients Assessed for Safety and Tolerability | 5 participants |
Secondary
Evaluating Tumor Destruction or Reduction
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.
Time frame: 2 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Open Label Treatment | Evaluating Tumor Destruction or Reduction | 5 Participants |