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Trial record 1 of 1 for:    NCT04429503
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Study of a High-Dose Aflibercept in Participants With Diabetic Eye Disease (PHOTON)

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ClinicalTrials.gov Identifier: NCT04429503
Recruitment Status : Active, not recruiting
First Posted : June 12, 2020
Last Update Posted : May 24, 2023
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Study Description
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Brief Summary:

The primary objective of the study is to determine if treatment with high-dose aflibercept (HD) at intervals of 12 or 16 weeks provides non-inferior best corrected visual acuity (BCVA) compared to aflibercept dosed every 8 weeks.

The secondary objectives of the study are as follows:

  • To determine the effect of HD vs. aflibercept on anatomic and other visual measures of response
  • To evaluate the safety, immunogenicity, and pharmacokinetics (PK) of aflibercept

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Type 1 Diabetes Mellitus Type 2 Diabetes Mellitus Drug: aflibercept Drug: High-dose aflibercept Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 660 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Masked, Active-Controlled Phase 2/3 Study of the Efficacy and Safety of High-Dose Aflibercept in Patients With Diabetic Macular Edema
Actual Study Start Date : June 29, 2020
Actual Primary Completion Date : May 30, 2022
Estimated Study Completion Date : June 29, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: aflibercept Q8
Administered every 8 weeks after a loading phase
 Drug: aflibercept
Intravitreally (IVT) administered as a liquid formulation in a vial
Other Names:
  • EYLEA®
  • BAY86-5321
Experimental: High-Dose aflibercept Q12
Administered every 12 weeks after a loading phase
 Drug: High-dose aflibercept
Intravitreally (IVT) administered as a liquid formulation in a vial
Experimental: High-Dose aflibercept Q16
Administered every 16 weeks after a loading phase
 Drug: High-dose aflibercept
Intravitreally (IVT) administered as a liquid formulation in a vial


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in best corrected visual acuity (BCVA) [ Time Frame: At Week 48 ]

Secondary Outcome Measures :
  1. Proportion of participants with a ≥2 step improvement in Diabetic Retinopathy Severity Scale (DRSS) [ Time Frame: At Week 48 ]
    The DRSS was assessed according to the following scale: 10 = Diabetic retinopathy (DR) absent, 14 = DR questionable, 15 = DR questionable, 20 = Micro-aneurysms only, 35 = Mild Non-proliferative diabetic retinopathy (NPDR), 43 = Moderate NPDR, 47 = Moderately severe NPDR, 53 = Severe NPDR, 61 = Mild Proliferative diabetic retinopathy (PDR), 65 = Moderate PDR, 71 = High-risk PDR, 75 = High-risk PDR, 81 = Advanced PDR: fundus partially obscured, center of macula attached, 85 = Advanced PDR: posterior fundus obscured, or center of macula detached, 90 = cannot grade, even sufficiently for level 81 or 85.

  2. Change from baseline in best corrected visual acuity (BCVA) (region-specific analysis) [ Time Frame: At Week 60 ]
  3. Proportion of participants gaining ≥15 letters [ Time Frame: At Week 48 ]
  4. Proportion of participants with BCVA ≥69 letters [ Time Frame: At Week 48 ]
  5. Proportion of participants without fluid at foveal center [ Time Frame: At Week 48 ]
  6. Change from baseline in central retinal thickness (CRT) [ Time Frame: At Week 48 ]
  7. Proportion of participants without leakage on fluorescein angiography (FA) [ Time Frame: At Week 48 ]
  8. Change from baseline in National Eye Institute Visual Function Questionnaire (NEI-VFQ) total score [ Time Frame: At Week 48 ]
    Vision-specific quality of life is assessed with the NEI VFQ-25 (National Eye Institute Visual Function Questionnaire), i.e. a 25-item questionnaire that gives a score on a scale from 0 (worst) to 100 (best = no vision problems).

  9. Systemic pharmacokinetics (PK) of aflibercept as assessed by plasma concentrations [ Time Frame: Through Week 48 ]
  10. Assessment of immunogenicity to aflibercept by measuring the incidence of treatment-emergent anti-drug antibodies (ADA) response [ Time Frame: Through Week 96 ]
  11. Safety assessed by adverse events (AEs) [ Time Frame: Through Weeks 48, 60, 96 and 156 ]
  12. Safety assessed by serious adverse events (SAEs) [ Time Frame: Through Weeks 48, 60, 96 and 156 ]
  13. Change from baseline in BCVA for participants with both baseline and week 48 BCVA, in the analysis subset [ Time Frame: At Week 48 ]
    Per SAP Version 2.0 Appendix 10.9 for US Only

  14. Change from 8-weeks post initial treatment phase in BCVA for participants with both 8-weeks post initial treatment phase BCVA and week 48 BCVA, in the analysis subset [ Time Frame: At Week 48 ]
    Per SAP Version 2.0 Appendix 10.9 for US Only


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Diabetic macular edema (DME) with central involvement in the study eye
  • Best corrected visual acuity (BCVA) early treatment diabetic retinopathy study (ETDRS) letter score of 78 to 24 (approximate Snellen equivalent of 20/32 to 20/320) in the study eye with decreased vision determined to be primarily the result of DME
  • Willing and able to comply with clinic visits and study-related procedures
  • Provide informed consent signed by study participant or legally acceptable representative

Extension Phase: 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.

Key Exclusion Criteria:

  • Evidence of macular edema due to any cause other than diabetes mellitus in either eye
  • Active proliferative diabetic retinopathy in the study eye
  • IVT anti-VEGF treatment (aflibercept, ranibizumab, bevacizumab, brolucizumab, pegaptanib sodium) or panretinal laser photocoagulation (PRP) /macular laser photocoagulation within 12 weeks (84 days) or intraocular or periocular corticosteroids within 16 weeks (112 days) of the screening visit in the study eye
  • Prior IVT investigational agents in either eye (eg, anti-ang-2/anti-VEGF bispecific monoclonal antibodies, gene therapy, etc.) at any time
  • Treatment with ocriplasmin (JETREA®) in the study eye at any time

NOTE: Other Protocol Defined Inclusion/Exclusion Criteria Apply

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04429503


Locations
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Sponsors and Collaborators
Regeneron Pharmaceuticals
Bayer
Investigators
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals
More Information
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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04429503    
Other Study ID Numbers: VGFTe-HD-DME-1934
2019-003643-30 ( EudraCT Number )
First Posted: June 12, 2020    Key Record Dates
Last Update Posted: May 24, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All IPD that underlie results in a publication.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Individual de-identified participant data will be made available once the indication has been approved by a regulatory body, if there is participant consent and there is not a reasonable likelihood of participant re-identification.
Access Criteria: Qualified researchers may request access to study documents (including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan) that support the methods and findings reported in a manuscript. Individual de-identified participant data will be made available once the indication has been approved by a regulatory body, if there is participant consent and there is not a reasonable likelihood of participant re-identification.
URL: https://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Macular Edema
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Macular Degeneration
 Retinal Degeneration
Retinal Diseases
Eye Diseases
Aflibercept
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents