Role of Intravitreal Aflibercept Injection for the Treatment of Radiation Maculopathy

NCT02586727 | Completed Phase 2 Results

• 1 other identifier: LCH-1-012015
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Adverse Effect of Radiation Therapy

Keywords

Radiation Retinopathy; aflibercept

Outcome Measures

Primary Outcomes (1)

• Mean Best Corrected Visual Acuity (BCVA) in Patients Treated With Intravitreal Aflibercept Injections for the Management of Radiation Maculopathy.

  BCVA will be measured with letter optotypes. A lower value indicates a better outcome.

  12 months

Secondary Outcomes (1)

• Role of Intravitreal Aflibercept Injection on Central Retinal Thickness for the Treatment of Radiation Maculopathy.

  12 months

Study Arms (2)

six week dosing regimen arm

ACTIVE COMPARATOR

Patients will receive an intravitreal aflibercept injection the first visit, and then again every six weeks. Treatment will be given at each visit.

Drug: aflibercept

treat and extend dosing regimen arm

ACTIVE COMPARATOR

Patients will receive an intravitreal aflibercept injection the first visit, again at the second visit at 6 weeks, and then begin treat and extend from second injection forward. Patients with decreased radiation maculopathy by one grade or more will extend re-evaluation by two weeks. Patients with increased radiation maculopathy by one grade or more will have re-evaluation decreased by one week. Patients that show no maculopathy grade change will remain at the same re-evaluation interval.

Drug: aflibercept

Interventions

aflibercept DRUG

This study will consist of 2 simultaneous treatment arms of aflibercept: A six week dosing regimen arm and a treat and extend (TAE) dosing regimen arm, total duration 54 weeks. In the TAE arm the patients will receive an intravitreal aflibercept injection first visit, again at the second visit at 6 weeks, and then begin treat and extend from second injection forward.

Also known as: Eylea

six week dosing regimen arm; treat and extend dosing regimen arm

Eligibility Criteria

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

You may qualify if:

• years of age and over
• /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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Larkin Community Hospital: lead

MeSH Terms

Conditions

Radiation Injuries

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Wounds and Injuries

Results Point of Contact

• Title: Dr. Timothy Murray
• Organization: Murray Ocular Oncology & Retina

tmurray@murraymd.com

3054877470

Study Officials

• Timothy G Murray, MD, MBA

  Murray Ocular Oncology & Retina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2015
• First Posted: October 26, 2015
• Study Start: October 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: August 1, 2020
• Last Updated: October 19, 2023
• Results First Posted: May 11, 2021

Record last verified: 2023-10