Phase 1
N=5
Effect of Ranibizumab on Malignant Conjunctival Neoplasia
Conjunctival Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT00456495 ↗Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Jun 2013
Primary outcome: Primary: Number of Patients Assessed for Safety and Tolerability — 5 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- ranibizumab (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- The New York Eye Cancer Center
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Assessed for Safety and Tolerability |
5 | — |
| SECONDARY Evaluating Tumor Destruction or Reduction |
5 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00456495). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.