High Dose Intravitreal Ranibizumab for Recalcitrant Radiation Retinopathy

Sponsor

The New York Eye Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT01334879

Collaborator

Genentech, Inc. (Industry)

Enrollment

Location

Arms

18.1

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Radiation Retinopathy	Drug: ranibizumab 2.0 mg	Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

High Dose (2.0mg) Intravitreal Ranibizumab for Recalcitrant Radiation Retinopathy

Study Start Date :

May 1, 2011

Actual Primary Completion Date :

Nov 1, 2012

Actual Study Completion Date :

Nov 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: With Loading Doses 5 patients will receive intravitreal injections every 30 days (+/- 7 days) for the first 4 months and every month thereafter until month 12 (maximum of 12 injections)	Drug: ranibizumab 2.0 mg Intravitreal ranibizumab (2.0 mg) Other Names: Lucentis
Active Comparator: Physician Discretion 5 patients will receive intravitreal ranibizumab every 30 days (+/- 7 days) on as needed basis based on the criteria defined in the study.	Drug: ranibizumab 2.0 mg Intravitreal ranibizumab (2.0 mg) Other Names: Lucentis

Arm

Intervention/Treatment

Active Comparator: With Loading Doses

5 patients will receive intravitreal injections every 30 days (+/- 7 days) for the first 4 months and every month thereafter until month 12 (maximum of 12 injections)

Drug: ranibizumab 2.0 mg

Intravitreal ranibizumab (2.0 mg)

Other Names:

Lucentis

Active Comparator: Physician Discretion

5 patients will receive intravitreal ranibizumab every 30 days (+/- 7 days) on as needed basis based on the criteria defined in the study.

Drug: ranibizumab 2.0 mg

Intravitreal ranibizumab (2.0 mg)

Other Names:

Lucentis

Outcome Measures

Primary Outcome Measures

Number of participants with adverse events (allergy, infection, or change in vital signs) [Baseline, at day 7, then monthly]
All subjects will be assessed at baseline, at 7 days after first injection, and monthly for adverse events. The primary outcome measures for safety and tolerability are: 1. incidence and severity of ocular adverse events, as identified by eye examination (including best corrected visual acuity testing) and 2. Incidence and severity of other adverse events, as identified by physical examination, subject reporting, and changes in vital signs

Secondary Outcome Measures

Number of participants with changes in central foveal thickness [Monthly, Report at Month 12]
This secondary outcome measure will evaluate the effect of ranibizumab in both groups (arms) on Regression of radiation retinopathy as measured by mean change in central retinal thickness as measured on optical coherence tomography (OCT) compared to baseline
Number of participants with changes in visual acuity [Monthly, Report at Month 12]
Each month each subject will be tested for best corrected visual acuity as compared to baseline.
Number of injections each group (arm) has received [Monthly, Report at Month 12]
Each group (arm) will be assessed for the number of monthyl injections received through Month 12.
Number of participants with qualitative changes in retinopathy on ophthalmoscopy and fluorescein angiography [Monthly Report at Month 12]
Evaluation of both arms on qualitative change in exudates, retinal hemorrhage, microaneurym and neovascularization) as seen on ophthalmoscopy/color photography and fluorescein angiography compared to baseline.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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