Intravitreal Aflibercept Injection for Radiation Retinopathy

NCT ID: NCT01579760

Last Updated: 2019-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2019-03-27

Brief Summary

The purpose of this study is to assess the safety of intravitreal aflibercept injection - in the treatment of macular edema associated with retinopathy secondary to previous radiation therapy.

Detailed Description

Radiation retinopathy can cause decreased vision in patients who have received either external beam radiation or local plaque therapy to the eye. An early manifestation of radiation retinopathy is macular edema, which represents fluid within the retina that affects central vision. There is currently no approved treatment for this disease, although there have been anecdotal reports of benefit with laser photocoagulation, intravitreal anti-VEGF agents, or intravitreal steroid use. This is a phase 1 study to evaluate aflibercept for the treatment of macular edema associated with retinopathy secondary to previous radiation treatment.

Conditions

Radiation Retinopathy; Macular Edema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

aflibercept every 2 months

Group Type: EXPERIMENTAL

Aflibercept every 2 months

Intervention Type: DRUG

2.0 mg aflibercept intravitreal injections once per month for the first 3 months (M0, M1, M2), then every 2 months (M4, M6, M8, M10)

aflibercept monthly

Group Type: EXPERIMENTAL

Aflibercept monthly

Intervention Type: DRUG

2.0mg aflibercept intravitreal injections every month (M0-11)

Interventions

Aflibercept every 2 months

2.0 mg aflibercept intravitreal injections once per month for the first 3 months (M0, M1, M2), then every 2 months (M4, M6, M8, M10)

Intervention Type: DRUG

Aflibercept monthly

2.0mg aflibercept intravitreal injections every month (M0-11)

Intervention Type: DRUG

Other Intervention Names

EYLEA; VEGF Trap-Eye; EYLEA; VEGF Trap-Eye

Eligibility Criteria

Inclusion Criteria

• Retinopathy associated with previous I-125 brachytherapy for uveal melanoma (85 Gy over 96 hours) at least 6 months prior to enrollment
• Ability to provide written informed consent and comply with study assessments for the full duration of the study
• Age > 18 years
• Center involved macular edema > 300µm in thickness on SD-OCT
• Best corrected visual acuity of 20/40- 20/400
• Birth control therapy for females of child-bearing age

Exclusion Criteria

• Pre-existing retinopathy due to other disorders
• Vision decrease is considered to be due to ischemic radiation retinopathy without macular edema or optic neuropathy
• Presence of metastasis
• 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.
• Prior enrollment in any study with intravitreal aflibercept injection
• Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
• Uncontrolled glaucoma in the study eye (defined as IOP ≥ 30 mmHg despite treatment with anti-glaucoma medication)
• History of cerebral vascular accident, myocardial infarction, transient ischemic attacks within 4 months of study enrollment.
• Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
• Any concurrent intraocular condition in the study eye (e.g., cataract or diabetic retinopathy) that, in the opinion of the investigator, could either require medical or surgical intervention during the study period to prevent or treat visual loss that might result from that condition, or if allowed to progress untreated, could likely contribute to loss of at least 2 Snellen equivalent lines of BCVA over the 6-month study period
• Presence of significant subfoveal fibrosis or atrophy
• Intraocular surgery (including cataract surgery) in the study eye within 2 months of enrollment
• Active intraocular inflammation (grade trace or above) in the study eye
• History of allergy to fluorescein, ICG or iodine, not amenable to treatment
• Prior/Concomitant Treatment:
• Panretinal photocoagulation treatment
• Previous intraocular steroids or PDT within 3 months
• Previous participation in any studies of investigational drugs within 30 days preceding Day 0 (excluding vitamins and minerals)
• Previous treatment with intravitreally (in either eye) or intravenously administered Avastin (bevacizumab) within 60 days or concomitant use in either eye outside the scope of this study
• Previous use of Eylea, Macugen or Lucentis in study eye within 60 days or concomitant use in either eye outside the scope of this study
• Prior submacular or vitreous surgery

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Prabakar K Rao, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Retina Consultants of Houston

Houston, Texas, United States

Countries

United States

References

Horgan N, Shields CL, Mashayekhi A, Teixeira LF, Materin MA, Shields JA. Early macular morphological changes following plaque radiotherapy for uveal melanoma. Retina. 2008 Feb;28(2):263-73. doi: 10.1097/IAE.0b013e31814b1b75.

Reference Type: BACKGROUND

PMID: 18301032 (View on PubMed)

Finger PT, Chin K. Anti-vascular endothelial growth factor bevacizumab (avastin) for radiation retinopathy. Arch Ophthalmol. 2007 Jun;125(6):751-6. doi: 10.1001/archopht.125.6.751.

Reference Type: BACKGROUND

PMID: 17562985 (View on PubMed)

Wen JC, McCannel TA. Treatment of radiation retinopathy following plaque brachytherapy for choroidal melanoma. Curr Opin Ophthalmol. 2009 May;20(3):200-4. doi: 10.1097/ICU.0b013e328329b62d.

Reference Type: BACKGROUND

PMID: 19349865 (View on PubMed)

Other Identifiers

aflibercept2012

Identifier Type: -

Identifier Source: org_study_id