DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Effect of Intravitreal Ranibizumab on Radiation Retinopathy Following Plaque Brachytherapy for Choroidal Melanoma

Information source: The New York Eye Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Radiation Retinopathy; Choroidal Melanoma

Intervention: Ranibizumab (Drug); ranibizumab (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: The New York Eye Cancer Center

Official(s) and/or principal investigator(s):
Paul T Finger, MD, Principal Investigator, Affiliation: The New York Eye Cancer Center

Summary

This is a Phase I clinical trial to test the safety and tolerability of intravitreal ranibizumab in the treatment of radiation retinopathy following plaque brachytherapy for patients with choroidal melanoma using the incidence and severity of events criteria. The secondary objective is to assess the efficacy of intravitreal ranibizumab on regression of radiation retinopathy by ophthalmic examination, fundus photography, fluorescein angiography, and optical coherence tomography, as well as visual acuity.

Clinical Details

Official title: An Open Label Study to Evaluate the Effect of Intravitreal Ranibizumab on Radiation Retinopathy Following Plaque Brachytherapy for Choroidal Melanoma

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: To test the safety and tolerability of intravitreal ranibizumab in the treatment of radiation retinopathy associated with plaque brachytherapy for choroidal melanoma

Secondary outcome: To assess the efficacy of intravitreal ranibizumab on treating radiation retinopathy following plaque brachytherapy for choroidal melanoma, and effect on visual acuity

Detailed description: Following plaque brachytherapy as treatment for choroidal melanoma, patients may develop radiation retinopathy. Radiation retinopathy is a progressive condition that leads to blindness in over 50% of cases within 5 years of treatment. Vascular endothelial growth factor (VEGF) protein is believed to play a critical role in angiogenesis and radiation retinopathy. It is one of the key contributors to physiological or pathological conditions that can stimulate both the formation of new blood vessels and normal vessel incompetence. Ranibizumab is a recently approved vascular endothelial growth factor (VEGF) inhibitor shown to be effective in treating exudative 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. This is an open label, non-randomized active treatment, Phase I trial to assess the safety and tolerability of intravitreal ranibizumab and its ability to reduce radiation retinopathy and potentially limit vision loss associated with this disease.

Eligibility

Minimum age: 21 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Diagnosis of radiation retinopathy

- History of choroidal melanoma status post plaque brachytherapy

- Age > 21 years

- Ability to perform written consent and comply with study assessments for the full

duration of the study Exclusion Criteria:

- Pregnancy or lactation, pre-menopausal women not using contraception

- Participation in another simultaneous medical investigation or trial

- Patient with significantly compromised visual acuity in the study eye due to

concomitant ocular conditions.

- Patients who have undergone intraocular surgery within last 60 days.

- Patients who have had intravitreal anti-VEGF treatment within 45 days.

- Patients who have had intravitreal triamcinolone acetonide within 4 months.

- Patients who have had laser within 60 days.

- Inability to obtain photographs to document CNV (including difficulty with venous

access).

- Patient has a history of any medical condition which would preclude scheduled visits

or completion of study.

- Aphakia or absence of the posterior capsule in the study eye. Previous violation of

the posterior capsule in the study eye is also excluded unless as a result of yttrium aluminum garnet (YAG) posterior capsulotomy in association with posterior chamber lens implantation..

- History of glaucoma filtering surgery in the study eye.

- Concurrent use of more than two therapies for glaucoma.

- Any other condition that the investigator believes would pose a significant hazard to

the subject if the investigational therapy were initiated

Locations and Contacts

The New York Eye Cancer Center, New York, New York 10065, United States
Additional Information

Related publications:

Finger PT. Radiation retinopathy is treatable with anti-vascular endothelial growth factor bevacizumab (Avastin). Int J Radiat Oncol Biol Phys. 2008 Mar 15;70(4):974-7. doi: 10.1016/j.ijrobp.2007.11.045.

Finger PT, Chin K. Anti-vascular endothelial growth factor bevacizumab (avastin) for radiation retinopathy. Arch Ophthalmol. 2007 Jun;125(6):751-6.

Starting date: October 2008
Last updated: April 25, 2012

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017