High Dose Intravitreal Ranibizumab for Recalcitrant Radiation Retinopathy

NCT01334879 | Completed Phase 1 DMC

• 1 other identifier: FVF4981S
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiation Retinopathy

Keywords

radiation; retinopathy; anti-VEGF; eye

Outcome Measures

Primary Outcomes (1)

• 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 (4)

• Number of participants with changes in central foveal thickness

  Monthly, Report at Month 12

• Number of participants with changes in visual acuity

  Monthly, Report at Month 12

• Number of injections each group (arm) has received

  Monthly, Report at Month 12

• Number of participants with qualitative changes in retinopathy on ophthalmoscopy and fluorescein angiography

  Monthly Report at Month 12

Study Arms (2)

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

Interventions

ranibizumab 2.0 mg DRUG

Intravitreal ranibizumab (2.0 mg)

Also known as: Lucentis

Physician Discretion; With Loading Doses

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The New York Eye Cancer Center: lead
• Genentech, Inc.: collaborator

Study Sites (1)

The New York Eye Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Dr. Finger's Radiation Retinopathy Studies

MeSH Terms

Conditions

Retinal Diseases

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Paul T Finger, MD

  The New York Eye Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 11, 2011
• First Posted: April 13, 2011
• Study Start: May 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: October 2, 2014

Record last verified: 2014-09

Locations

US (1)