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Completed

NCT Number: NCT00456495

Effect of Ranibizumab on Malignant Conjunctival Neoplasia

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.

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Key information

Conditions

Conjunctival Neoplasms Conjunctival Diseases Eye Diseases Eye Neoplasms Neoplasms Neoplasms by Site

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The New York Eye Cancer Center

New York, 10021, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ranibizumab

Drug

Subconjunctival injection of drug every 2 to 4 weeks

Other names: Lucentis

Primary outcomes

  1. Number of Patients Assessed for Safety and Tolerability

    Time frame: 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 outcomes

  1. Evaluating Tumor Destruction or Reduction

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The New York Eye Cancer Center

Other

Collaborators

  • Genentech, Inc.

Registry information

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Apr 5, 2007
Registry last updated
Jul 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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