Status:
COMPLETED
Effect of Intravitreal Ranibizumab on Radiation Retinopathy Following Plaque Brachytherapy for Choroidal Melanoma
Lead Sponsor:
The New York Eye Cancer Center
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Radiation Retinopathy
Choroidal Melanoma
Eligibility:
All Genders
21+ years
Phase:
PHASE1
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 me...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00750399
Start Date
October 1 2008
End Date
September 1 2011
Last Update
April 26 2012
Active Locations (1)
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1
The New York Eye Cancer Center
New York, New York, United States, 10065