Trial Outcomes & Findings for Role of Intravitreal Aflibercept Injection for the Treatment of Radiation Maculopathy (NCT NCT02586727)

NCT ID: NCT02586727

Last Updated: 2023-10-19

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 40 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2023-10-19

Participant Flow

Participant milestones

Measure	Six Week Dosing Regimen Arm Patients will receive an intravitreal aflibercept injection the first visit, and then again every six weeks. Treatment will be given at each visit. aflibercept: 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.	Treat and Extend Dosing Regimen Arm 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. aflibercept: 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.
Overall Study STARTED	20	20
Overall Study COMPLETED	19	20
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Six Week Dosing Regimen Arm Patients will receive an intravitreal aflibercept injection the first visit, and then again every six weeks. Treatment will be given at each visit. aflibercept: 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.	Treat and Extend Dosing Regimen Arm 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. aflibercept: 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.
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

Role of Intravitreal Aflibercept Injection for the Treatment of Radiation Maculopathy

Baseline characteristics by cohort

Measure	Six Week Dosing Regimen Arm n=20 Participants Patients will receive an intravitreal aflibercept injection the first visit, and then again every six weeks. Treatment will be given at each visit. aflibercept: 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.	Treat and Extend Dosing Regimen Arm n=20 Participants 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. aflibercept: 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.	Total n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants	7 Participants n=7 Participants	19 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants	13 Participants n=7 Participants	21 Participants n=5 Participants
Age, Continuous	62 Years n=5 Participants	67.3 Years n=7 Participants	64.7 Years n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	8 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	12 Participants n=7 Participants	20 Participants n=5 Participants
Race/Ethnicity, Customized White, Non-Hispanic	19 Participants n=5 Participants	18 Participants n=7 Participants	37 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Baseline study entry mean BCVA was 20/63 (Logmar 0.498)

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

Outcome measures

Measure	Six Week Dosing Regimen Arm n=20 Participants Patients will receive an intravitreal aflibercept injection the first visit, and then again every six weeks. Treatment will be given at each visit. aflibercept: 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.	Treat and Extend Dosing Regimen Arm n=20 Participants 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. aflibercept: 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.
Mean Best Corrected Visual Acuity (BCVA) in Patients Treated With Intravitreal Aflibercept Injections for the Management of Radiation Maculopathy.	0.425 Log MAR (Visual Acuity) Interval 0.0 to 1.602	0.548 Log MAR (Visual Acuity) Interval 0.097 to 1.602

SECONDARY outcome

Timeframe: 12 months

Central retinal thickness will be evaluated with OCT. A lower value considered a better outcome.

Outcome measures

Measure	Six Week Dosing Regimen Arm n=20 eye Patients will receive an intravitreal aflibercept injection the first visit, and then again every six weeks. Treatment will be given at each visit. aflibercept: 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.	Treat and Extend Dosing Regimen Arm n=20 eye 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. aflibercept: 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.
Role of Intravitreal Aflibercept Injection on Central Retinal Thickness for the Treatment of Radiation Maculopathy.	298 microns Interval 154.0 to 482.0	294 microns Interval 192.0 to 595.0

Adverse Events

Six Week Dosing Regimen Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Treat and Extend Dosing Regimen Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Timothy Murray

Murray Ocular Oncology & Retina

Phone: 3054877470

Email: tmurray@murraymd.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place