high dose intravitreal ranibizumab for recalcitrant radiation retinopathy

Conditions: Radiation Retinopathy

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.

this study is an open-label, phase i study of intravitreally administered ranibizumab in subjects with radiation retinopathy. this is a single center, non-randomized, active treatment study involving 10 consecutive patients. this study will evaluate the safety and tolerability of a high dose (2.0 mg) intravitreal ranibizumab and its effect on regression of radiation retinopathy and mean change in visual acuity.

Eligibility 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

Keywords: radiation retinopathy anti-vegf eye