High Dose Intravitreal Ranibizumab for Recalcitrant Radiation Retinopathy

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This study investigates the use of a high dose anti-VEGF agent for the treatment of radiation retinopathy in those patients who have recalcitrant disease.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The New York Eye Cancer Center
• Collaborator: Genentech, Inc.
• Treatments: Ranibizumab

Criteria

Inclusion Criteria

Subjects will be eligible if the following criteria are met:

• Ability to provide written informed consent and comply with study assessments for the full duration of the study

• Age > 21 years

• History of a clinical diagnosis of radiation retinopathy

• Subjects who are at least 3 months and no more than 10 years from radiation therapy

• History of prior treatment for radiation retinopathy with incomplete response (eg. persistent edema, presence of hemorrhage, presence of exudates, etc

• ETDRS best corrected visual acuity of 20/400 or better in the study eye

• Ability to return for all study visits

Exclusion Criteria

Subjects who meet any of the following criteria will be excluded from this study:

• 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.

• 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

• Subject with significantly compromised visual acuity in the study eye due to concomitant ocular conditions.

• Subjects who have undergone intraocular surgery within last 60 days.

• Subjects who have had intravitreal anti-VEGF treatment within 30 days.

• Subjects who have had intravitreal triamcinolone acetonide within 4 months.

• Subjects who have had laser within 60 days.

• Inability to obtain photographs to document CNV (including difficulty with venous access).

• Subject with known adverse reaction to fluorescein dye.

• Subject 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.

• Uncontrolled glaucoma in the study eye (defined as intraocular pressure >30 mm Hg despite treatment with anti-glaucoma medication)

• Inability to comply with study or follow-up procedure