Clinical trial NCT01334879: High Dose Intravitreal Ranibizumab for Recalcitrant Radiation Retinopathy
Official title: High Dose (2.0mg) Intravitreal Ranibizumab for Recalcitrant Radiation Retinopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Radiation Retinopathy
Keywords: radiation
retinopathy
anti-VEGF
eye
Lead sponsor: The New York Eye Cancer Center
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2011-04-13
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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

Primary outcomes:
measure: Number of participants with adverse events (allergy, infection, or change in vital signs)
timeFrame: Baseline, at day 7, then monthly
Secondary outcomes:
measure: Number of participants with changes in central foveal thickness
timeFrame: Monthly, Report at Month 12
measure: Number of participants with changes in visual acuity
timeFrame: Monthly, Report at Month 12
measure: Number of injections each group (arm) has received
timeFrame: Monthly, Report at Month 12
measure: Number of participants with qualitative changes in retinopathy on ophthalmoscopy and fluorescein angiography
timeFrame: Monthly Report at Month 12
Other outcomes:
Locations:
city: New York
country: United States
facility: The New York Eye Cancer Center
state: New York
Study officials:
affiliation: The New York Eye Cancer Center
name: Paul T Finger, MD
role: PRINCIPAL_INVESTIGATOR
References: