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

Choroidal Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00750399
• Other study ID #: FVF4519s
• Status: Completed
• Phase: Phase 1
• First received: September 9, 2008
• Last updated: April 25, 2012
• Start date: October 2008
• Est. completion date: September 2011

Study information

• Verified date: April 2012
• Source: The New York Eye Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Choroidal Melanoma
• Melanoma
• Radiation Retinopathy
• Retinal Diseases

Intervention

Drug:
• Ranibizumab
intravitreal ranibizumab monthly for 4 months, and then every month thereafter until month 12.
• ranibizumab
intravitreal ranibizumab 0.5 mg

Locations

Country	Name	City	State
United States	The New York Eye Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
The New York Eye Cancer Center	Genentech, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (3)

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

Finger PT, Chin KJ. Intravitreous ranibizumab (lucentis) for radiation maculopathy. Arch Ophthalmol. 2010 Feb;128(2):249-52. doi: 10.1001/archophthalmol.2009.376. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To test the safety and tolerability of intravitreal ranibizumab in the treatment of radiation retinopathy associated with plaque brachytherapy for choroidal melanoma		12 months	Yes
Secondary	To assess the efficacy of intravitreal ranibizumab on treating radiation retinopathy following plaque brachytherapy for choroidal melanoma, and effect on visual acuity		12 months	No