Phase 2 N=40 Randomized Treatment

Role of Intravitreal Aflibercept Injection for the Treatment of Radiation Maculopathy

Adverse Effect of Radiation Therapy

Bottom Line

View on ClinicalTrials.gov: NCT02586727 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2021

Primary outcome: Primary: Mean Best Corrected Visual Acuity (BCVA) in Patients Treated With Intravitreal Aflibercept Injections for the Management of Radiation Maculopathy. — 0.425; 0.548 Log MAR (Visual Acuity)

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: aflibercept (Drug)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: Larkin Community Hospital
Primary completion: Dec 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Best Corrected Visual Acuity (BCVA) in Patients Treated With Intravitreal Aflibercept Injections for the Management of Radiation Maculopathy.	0.425; 0.548	—
SECONDARY Role of Intravitreal Aflibercept Injection on Central Retinal Thickness for the Treatment of Radiation Maculopathy.	298; 294	—

Summary

The primary objective of the study is to assess the safety of intravitreal aflibercept injection in treating visually compromising radiation maculopathy secondary to treatment of uveal melanoma by iodione-125 brachytherapy. The study will consist of two arms of 25 patients each (totaling 50 patients). Subjects in arm 1 will undergo treatment every 6 weeks. Subjects in arm 2 will undergo treatment and if improvement is documented at the following evaluation the next treatment will be extended by two weeks. Secondary objectives of the study include evaluation and analysis of visual acuity, number of injections, macular edema, and vascular activity between both arms.

Eligibility Criteria

Inclusion Criteria

A Patient must meet the following criteria to be eligible for inclusion in the study:
21 years of age and over
20/800 or better visual acuity
Must have received previous treatment for radiation maculopathy within the last 4-26 weeks
Any presence of macular edema (evaluated by SD-OCT) caused by radiation retinopathy
Willing and able to comply with clinic visits and study-related procedures
Provide signed informed consent

Exclusion Criteria

A patient who meets any of the following criteria will be excluded from the study:
Patients less than 21 years of age.
Patients with mental disability or any other condition that precludes the acquisition of an sdOCT image such as (nystagmus, neck disease, etc.)
Patients who have previously been treated with intravitreal triamcinolone acetonide for macular edema (signs of recalcitrant disease)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02586727). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.