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

Phase 1
21 Years
Open (Enrolling)
Radiation Retinopathy

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Trial Information

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

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.

Inclusion 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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of participants with adverse events (allergy, infection, or change in vital signs)

Outcome Description:

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

Outcome Time Frame:

Baseline, at day 7, then monthly

Safety Issue:


Principal Investigator

Paul T Finger, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The New York Eye Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

May 2011

Completion Date:

November 2012

Related Keywords:

  • Radiation Retinopathy
  • radiation
  • retinopathy
  • anti-VEGF
  • eye
  • Retinal Diseases



The New York Eye Cancer Center New York, New York  10021