High Dose Intravitreal Ranibizumab for Recalcitrant Radiation Retinopathy

The New York Eye Cancer Center

Status and phase: Completed; Phase 1

Conditions: Radiation Retinopathy

Treatments: Drug: ranibizumab 2.0 mg

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01334879

FVF4981S

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

10 participants in 2 patient groups

With Loading Doses

Active Comparator group

Description:

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)

Treatment:

Drug: ranibizumab 2.0 mg

Physician Discretion

Active Comparator group

Description:

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

Treatment:

Drug: ranibizumab 2.0 mg