Intravitreal Aflibercept Injection for Radiation Retinopathy

NCT01579760 | Completed Phase 1 DMC

• 1 other identifier: aflibercept2012
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 2

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.

Conditions

Radiation Retinopathy; Macular Edema

Keywords

radiation; retinopathy; macular edema; anti-VEGF; VEGF-Trap; aflibercept

Outcome Measures

Primary Outcomes (2)

• Incidence of adverse events

  12 months

• Severity of adverse events

  12 months

Secondary Outcomes (8)

• Mean change in best corrected visual acuity from baseline

  12 months

• Mean change in central foveal thickness by optical coherence tomography (OCT) from baseline

  12 months

• Mean visual acuity

  12 months

• Mean central foveal thickness

  12 months

• Proportion of patients gaining 3 lines of vision

  12 months

Study Arms (2)

aflibercept every 2 months

EXPERIMENTAL

Drug: Aflibercept every 2 months

aflibercept monthly

EXPERIMENTAL

Drug: Aflibercept monthly

Interventions

Aflibercept every 2 months 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)

Also known as: EYLEA, VEGF Trap-Eye

aflibercept every 2 months

Aflibercept monthly DRUG

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

Also known as: EYLEA, VEGF Trap-Eye

aflibercept monthly

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (2)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Retina Consultants of Houston

Houston, Texas, 77030, United States

Location

Related Publications (3)

• 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.

  PMID: 18301032 BACKGROUND

• 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.

  PMID: 17562985 BACKGROUND

• 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.

  PMID: 19349865 BACKGROUND

MeSH Terms

Conditions

Macular Edema; Retinal Diseases

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Eye Diseases

Study Officials

• Prabakar K Rao, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2012
• First Posted: April 18, 2012
• Study Start: November 1, 2012
• Primary Completion: January 1, 2019
• Study Completion: March 27, 2019
• Last Updated: April 25, 2019

Record last verified: 2019-04

Locations

US (2)