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

NCT00750399 | Completed Phase 1

• 1 other identifier: FVF4519s
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Radiation Retinopathy; Choroidal Melanoma

Keywords

radiation; retinopathy; ranibizumab; melanoma; choroid

Outcome Measures

Primary Outcomes (1)

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

  12 months

Secondary Outcomes (1)

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

  12 months

Study Arms (1)

Intravitreal ranibizumab

EXPERIMENTAL

Patients will receive intravitreal ranibizumab on a monthly basis depending on response to treatment

Drug: Ranibizumab

Interventions

ranibizumab DRUG

intravitreal ranibizumab monthly for 4 months, and then every month thereafter until month 12.

Also known as: Lucentis

Intravitreal ranibizumab

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The New York Eye Cancer Center: lead
• Genentech, Inc.: collaborator

Study Sites (1)

The New York Eye Cancer Center

New York, New York, 10065, United States

Location

Related Publications (3)

• 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.

  PMID: 18313522 BACKGROUND

• Finger PT, Chin K. Anti-vascular endothelial growth factor bevacizumab (avastin) for radiation retinopathy. Arch Ophthalmol. 2007 Jun;125(6):751-6. doi: 10.1001/archopht.125.6.751.

  PMID: 17562985 BACKGROUND

• Finger PT, Chin KJ. Intravitreous ranibizumab (lucentis) for radiation maculopathy. Arch Ophthalmol. 2010 Feb;128(2):249-52. doi: 10.1001/archophthalmol.2009.376. No abstract available.

  PMID: 20142553 RESULT

MeSH Terms

Conditions

Uveal Melanoma; Retinal Diseases; Melanoma

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Uveal Neoplasms; Eye Neoplasms; Neoplasms by Site; Eye Diseases; Uveal Diseases; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Paul T Finger, MD

  The New York Eye Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: September 9, 2008
• First Posted: September 10, 2008
• Study Start: October 1, 2008
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: April 26, 2012

Record last verified: 2012-04

Locations

US (1)