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Monoclonal Antibodies

High-Dose Aflibercept for Diabetic Macular Edema (PHOTON Trial)

Phase 2 & 3
Waitlist Available
Research Sponsored by Regeneron Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diabetic macular edema (DME) with central involvement in the study eye
All randomized patients that complete visit 26, week 96, as long as the patient 1) provides informed consent and 2) no treatment for DME has been given in the study eye other than the randomized study treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through week 156
Awards & highlights

PHOTON Trial Summary

This trial is testing if a more concentrated dose of aflibercept, given less often, is as effective as the current standard dose given more often, in terms of improve vision.

Who is the study for?
This trial is for individuals with diabetic macular edema (DME) affecting their central vision, having a specific range of visual acuity. Participants must be able to attend clinic visits and follow study procedures. Those who have received certain other treatments or have conditions like proliferative diabetic retinopathy are excluded.Check my eligibility
What is being tested?
The study tests whether high-dose aflibercept given less frequently maintains vision as effectively as the standard dose given every 8 weeks. It also examines the drug's safety, immune response it may cause, and how it moves through and out of the body.See study design
What are the potential side effects?
While not specified here, common side effects of eye injections like aflibercept include redness, pain at injection site, blurred vision, floaters in the eye; serious but rare risks involve infection inside the eye or retinal detachment.

PHOTON Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have swelling in the center of my retina due to diabetes.
Select...
I completed week 96 of the study without any DME treatment other than the study's.
Select...
My vision in the study eye is between 20/32 and 20/320 due to diabetic macular edema.

PHOTON Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through week 156
This trial's timeline: 3 weeks for screening, Varies for treatment, and through week 156 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline in Best Corrected Visual Acuity (BCVA) (Early Treatment Diabetic Retinopathy Study [ETDRS] Letter Score) in the Study Eye at Week 48
Secondary outcome measures
Assessment of Immunogenicity to Aflibercept by Measuring the Incidence of Treatment-emergent Anti-drug Antibodies (ADA) Response Through Week 96
Change From 8-weeks Post Initial Treatment Phase in BCVA in the Study Eye in Participants With Both 8-weeks Post Initial Treatment Phase BCVA and Week 48 BCVA
Change From Baseline in BCVA (Region-specific Analysis) in the Study Eye at Week 60
+11 more

Side effects data

From 2021 Phase 2 trial • 106 Patients • NCT04126317
8%
Neovascular age-related macular degeneration Study Eye
6%
Vitreous detachment Fellow Eye
6%
Vitreous detachment Study Eye
6%
Neovascular age-related macular degeneration Fellow Eye
4%
Fall
4%
Conjunctival haemorrhage Study Eye
2%
Colitis
2%
Femur fracture
2%
COVID-19
2%
Visual acuity reduced Study Eye
2%
Conjunctival haemorrhage Fellow Eye
2%
Small intestinal obstruction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Intravitreal Aflibercept Injection (IAI)
High-Dose Aflibercept Injection (HD)

PHOTON Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: High-Dose aflibercept Q16Experimental Treatment1 Intervention
Administered every 16 weeks after a loading phase
Group II: High-Dose aflibercept Q12Experimental Treatment1 Intervention
Administered every 12 weeks after a loading phase
Group III: aflibercept Q8Active Control1 Intervention
Administered every 8 weeks after a loading phase
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
High-dose aflibercept
2019
Completed Phase 2
~110

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsLead Sponsor
615 Previous Clinical Trials
379,187 Total Patients Enrolled
BayerIndustry Sponsor
2,237 Previous Clinical Trials
25,326,318 Total Patients Enrolled
Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals
259 Previous Clinical Trials
250,384 Total Patients Enrolled

Media Library

Aflibercept (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04429503 — Phase 2 & 3
Diabetic Macular Edema Research Study Groups: High-Dose aflibercept Q12, High-Dose aflibercept Q16, aflibercept Q8
Diabetic Macular Edema Clinical Trial 2023: Aflibercept Highlights & Side Effects. Trial Name: NCT04429503 — Phase 2 & 3
Aflibercept (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04429503 — Phase 2 & 3
Diabetic Macular Edema Patient Testimony for trial: Trial Name: NCT04429503 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can you tell me how many different facilities are running this clinical trial?

"Currently, there are 86 sites running this clinical trial. They are based in New york, Kingston, Cleveland and other locations. To reduce the amount of travelling required, it is best to choose a location near you."

Answered by AI

Have any other research groups looked into the effects of high-dose aflibercept?

"M D Anderson Cancer Center pioneered high-dose aflibercept research in 2014. Currently, there are 227 completed studies and 49 ongoing clinical trials. New york, New York is one of the many places where high-dose aflibercept's efficacy is being investigated."

Answered by AI

How many test subjects are included in the sample size for this research?

"As of now, this particular clinical trial is not recruiting any more participants. The trial was first posted on 6/29/2020 and was last edited on 11/2/2022. If you are interested in other studies, 1667 clinical trials for type 2 diabetes mellitus and 49 trials for High-dose aflibercept are still recruiting patients."

Answered by AI

What condition does High-dose aflibercept usually target?

"Wet age-related macular degeneration (WAMD) is often managed with high-dose aflibercept. This treatment option can also be successful in cases of macular edema, diabetic macular edema (DME), and general macular degeneration."

Answered by AI

Who else is applying?

What state do they live in?
California
Florida
Missouri
Other
How old are they?
18 - 65
What site did they apply to?
Regeneron Study Site
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
2
3+
0

Why did patients apply to this trial?

I am desperate for help! for pdn which is bothersome. Would love to improve my vision.
PatientReceived no prior treatments
Las medicinas que tomo no me dan resultados. I am not satisfied with my current treatment.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

Is there one in Colorado Springs?
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Study of a High-Dose Aflibercept in Participants With Diabetic Eye Disease
2020. "Study of a High-Dose Aflibercept in Participants With Diabetic Eye Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04429503.
All > Macular Edema
~139 spots leftby Apr 2025
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