Intravitreal Aflibercept Injection for Radiation Retinopathy Trial

Conditions

• Radiation Retinopathy

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Aflibercept — DRUG
  The investigational product is intravitreal aflibercept injection (IAI), which will be supplied by Regeneron Pharmaceuticals, Inc. in sterile vials for intravitreal (IVT) injection. The study duration will be 52 weeks. Vials of drug must be used (defined as entered with needle) only once. All drug supplies are to be kept under recommended storage conditions. The injection volume will be 50μL (0.05 mL) and will be administered to the patients by IVT injection.

Study Details

The ARRT trial will assess the safety and efficacy of 2mg aflibercept for the treatment of radiation retinopathy, including maculopathy and optic neuropathy over 52 weeks.

Key Dates

Start date

Jul 5, 2017

Status verified

Dec 2020

Primary completion

Oct 31, 2021

Completion

Oct 31, 2021

Study Design

Enrollment

40 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Loading Dose
  20 Patients will receive 4, 2 mg IVT Aflibercept (IAI) a month apart, screening/baseline, weeks 4, 8, \& 12. At week 12, patient will be followed \& treated per treat \& extend protocol. Treat \& Extend Protocol entails patients being extended as long as: * Absence of retinal fluid (resolution of intraretinal \& subretinal fluid on SD-OCT; Small intraretinal cysts that don't distort foveal contour on SD-OCT are acceptable \& can be considered "dry".) AND * \< 5 ETDRS letter loss from previous visit, due to new or persistent retinal edema. Each extension will be 2 weeks in duration beyond the initial 4-week interval. If the extension criteria are not met on a follow-up visit, treatment interval will be reduced by 2 weeks. Follow up interval will continue to be reduced by 2 weeks until the extension criteria are met or a 4-week interval is reached.
• Experimental: Treat and Extend
  20 Patients will receive 2 mg IVT Aflibercept (IAI) at screening/baseline followed by a visit at week 4. At week 4, patient will be treated \& followed per the treat \& extend protocol. Treat \& Extend Protocol entails patients being extended as long as: * Absence of retinal fluid (resolution of intraretinal \& subretinal fluid on SD-OCT; Small intraretinal cysts that don't distort foveal contour on SD-OCT are acceptable \& can be considered "dry".) AND * \< 5 ETDRS letter loss from previous visit, due to new or persistent retinal edema. Each extension will be 2 weeks in duration beyond the initial 4-week interval. If the extension criteria are not met on a follow-up visit, treatment interval will be reduced by 2 weeks. Follow up interval will continue to be reduced by 2 weeks until the extension criteria are met or a 4-week interval is reached.

Primary Outcome Measure

Safety of intravitreal Aflibercept for the treatment of radiation retinopathy - Assessed by incidence of adverse events. [ Time Frame: 52 Weeks ]

Locations (3)

Find similar trials in Houston, TX

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