High Dose Intravitreal Ranibizumab for Recalcitrant Radia... | NCT01334879

NCT01334879

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
Genentech, Inc.	INDUSTRY

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
With Loading Doses	Active Comparator	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
Physician Discretion	Active Comparator	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

Name	Type	Description	Arm Group Labels	Other Names
ranibizumab 2.0 mg	Drug	Intravitreal ranibizumab (2.0 mg)	Physician Discretion With Loading Doses

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants with adverse events (allergy, infection, or change in vital signs)	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	Baseline, at day 7, then monthly

Secondary Outcomes

Measure	Description	Time Frame
Number of participants with changes in central foveal thickness	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	Monthly, Report at Month 12

Eligibility Module

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

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins