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Clinical Trial Details

Trial ID: L4752
Source ID: NCT04429503
Associated Drug: Aflibercept
Title: Study of a High-Dose Aflibercept in Participants With Diabetic Eye Disease
Acronym: PHOTON
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT04429503/results
Conditions: Diabetic Macular Edema|Type 1 Diabetes Mellitus|Type 2 Diabetes Mellitus
Interventions: DRUG: aflibercept|DRUG: High-dose aflibercept
Outcome Measures: Primary: Change From Baseline in Best Corrected Visual Acuity (BCVA) (Early Treatment Diabetic Retinopathy Study [ETDRS] Letter Score) in the Study Eye at Week 48, Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. BCVA scale range is 0 (worst) to 100 (best)., Baseline, Week 48 | Secondary: Percentage of Participants With a ≥2 Step Improvement From Baseline in Diabetic Retinopathy Severity Scale (DRSS) Score 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., Baseline, Week 48|Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline at Week 48, Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. BCVA scale range is 0 (worst) to 100 (best). Only one study eye per participant was analyzed within the study, Baseline, Week 48|Percentage of Participants With BCVA ≥69 Letters at Week 48, Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. BCVA scale range is 0 (worst) to 100 (best)., At Week 48|Percentage of Participants Without Fluid at Foveal Center at Week 48, Retinal fluid status was evaluated using spectral domain optical coherence tomography (SD-OCT) on the study eye., At Week 48|Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye at Week 48, Central Retinal Thickness (CRT) was measured in the study eye by spectral domain optical coherence tomography (SD-OCT)., Baseline, Week 48|Percentage of Participants Without Leakage on Fluorescein Angiography (FA) at Week 48, Leakage is the release of fluorescein dye from diseased retinal vessels., At Week 48|Change From Baseline in National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Total Score 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)., Baseline, Week 48|Systemic Pharmacokinetics (PK) of Aflibercept as Assessed by Plasma Concentrations Through Week 48, Concentrations of Free Aflibercept in Plasma by Time and Treatment Group, Through Week 48|Change From Baseline in BCVA in the Study Eye in Participants With Both Baseline and Week 48 BCVA, Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. BCVA scale range is 0 (worst) to 100 (best). (Per Statistical Analysis Plan (SAP) Version 2.0 Appendix 10.9 for US Only), Baseline, Week 48|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, Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. BCVA scale range is 0 (worst) to 100 (best). (Per SAP Version 2.0 Appendix 10.9 for US Only), Baseline, Week 48|Change From Baseline in BCVA (Region-specific Analysis) in the Study Eye at Week 60, Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. BCVA scale range is 0 (worst) to 100 (best)., Baseline, Week 60|Assessment of Immunogenicity to Aflibercept by Measuring the Incidence of Treatment-emergent Anti-drug Antibodies (ADA) Response Through Week 96, Number of participants with pre-existing immunoreactivity and treatment-emergent ADA response reported, Through Week 96|Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Through Week 96, A TEAE is an AE starting after the first dose of study drug to the last dose of study drug (active or sham) plus 30 days. Additionally, for patients who are still participating in the study (ie, have not been withdrawn and are continuing in the extension phase of the study) as of the week 96 visit all AEs up through the date of the week 96 visit were considered treatment-emergent., Through Week 96|Number of Participants With Any Serious TEAE Through Week 96, A TEAE is an AE starting after the first dose of study drug to the last dose of study drug (active or sham) plus 30 days. Additionally, for patients who are still participating in the study (ie, have not been withdrawn and are continuing in the extension phase of the study) as of the week 96 visit all AEs up through the date of the week 96 visit were considered treatment-emergent., Through Week 96
Sponsor/Collaborators: Sponsor: Regeneron Pharmaceuticals | Collaborators: Bayer
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2|PHASE3
Enrollment: 660
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2020-06-29
Completion Date: 2024-06-18
Results First Posted: 2023-11-21
Last Update Posted: 2024-07-30
Locations: Regeneron Study Site, Phoenix, Arizona, 85021, United States|Regeneron Study Site, Arcadia, California, 91006, United States|Regeneron Study Site, Beverly Hills, California, 90211, United States|Regeneron Study Site, Campbell, California, 95008, United States|Regeneron Study Site, Encino, California, 91436, United States|Regeneron Study Site, Fullerton, California, 92835, United States|Regeneron Study Site, Huntington Beach, California, 92647, United States|Regeneron Study Site, Long Beach, California, 90807, United States|Regeneron Study Site, Palo Alto, California, 94303, United States|Regeneron Study Site, Pasadena, California, 91107, United States|Regeneron Study Site, Poway, California, 92064, United States|Regeneron Study Site, Rancho Cordova, California, 95670, United States|Regeneron Study Site, Riverside, California, 92505, United States|Regeneron Study Site, Torrance, California, 90509, United States|Regeneron Study Site, Colorado Springs, Colorado, 80909, United States|Regeneron Study Site, Durango, Colorado, 81301, United States|Regeneron Study Site, Lakewood, Colorado, 80228, United States|Regeneron Study Site, Waterford, Connecticut, 06385, United States|Regeneron Study Site, Clearwater, Florida, 33761, United States|Regeneron Study Site, Fort Lauderdale, Florida, 33308, United States|Regeneron Study Site, Fort Myers, Florida, 33912, United States|Regeneron Study Site, Jacksonville, Florida, 32216, United States|Regeneron Study Site, Lakeland, Florida, 33805, United States|Regeneron Study Site, Largo, Florida, 33770, United States|Regeneron Study Site, Melbourne, Florida, 32901, United States|Regeneron Study Site, Miami, Florida, 33126, United States|Regeneron Study Site, Orlando, Florida, 32806, United States|Regeneron Study Site, Pinellas Park, Florida, 33782, United States|Regeneron Study Site, Plantation, Florida, 33324, United States|Regeneron Study Site, Saint Petersburg, Florida, 33711, United States|Regeneron Study Site, Stuart, Florida, 34994, United States|Regeneron Study Site, Winter Haven, Florida, 33880, United States|Regeneron Study Site, Augusta, Georgia, 30909, United States|Regeneron Study Site 1, Marietta, Georgia, 30060, United States|Regeneron Study Site 2, Marietta, Georgia, 30060, United States|Regeneron Study Site, 'Aiea, Hawaii, 96701, United States|Regeneron Study Site, Oak Forest, Illinois, 60452, United States|Regeneron Study Site, Springfield, Illinois, 62703, United States|Regeneron Study Site, Springfield, Illinois, 62704, United States|Regeneron Study Site, Carmel, Indiana, 46290, United States|Regeneron Study Site, Shawnee Mission, Kansas, 66204, United States|Regeneron Study Site, Baltimore, Maryland, 21209, United States|Regeneron Study Site, Hagerstown, Maryland, 21740, United States|Regeneron Study Site, Boston, Massachusetts, 02114, United States|Regeneron Study Site, Royal Oak, Michigan, 48073, United States|Regeneron Study Site, Southaven, Mississippi, 38671, United States|Regeneron Study Site, Henderson, Nevada, 89052, United States|Regeneron Study Site, Bloomfield, New Jersey, 07003, United States|Regeneron Study Site, Edison, New Jersey, 08820, United States|Regeneron Study Site, Teaneck, New Jersey, 07666, United States|Regeneron Study Site, Great Neck, New York, 11021, United States|Regeneron Study Site, Liverpool, New York, 13088, United States|Regeneron Study Site, New York, New York, 11221, United States|Regeneron Study Site, Oceanside, New York, 11572, United States|Regeneron Study Site, Shirley, New York, 02114, United States|Regeneron Study Site, Asheville, North Carolina, 28803, United States|Regeneron Study Site, Charlotte, North Carolina, 28210, United States|Regeneron Study Site, Beachwood, Ohio, 44122, United States|Regeneron Study Site, Cincinnati, Ohio, 45202, United States|Regeneron Study Site, Cincinnati, Ohio, 45242, United States|Regeneron Study Site, Cleveland, Ohio, 44130, United States|Regeneron Study Site, Dublin, Ohio, 43016, United States|Regeneron Study Site, Edmond, Oklahoma, 73013, United States|Regeneron Study Site, Tulsa, Oklahoma, 74114, United States|Regeneron Study Site, Portland, Oregon, 97225, United States|Regeneron Study Site, Bethlehem, Pennsylvania, 18017, United States|Regeneron Study Site, Kingston, Pennsylvania, 18704, United States|Regeneron Study Site, Monroeville, Pennsylvania, 15146, United States|Regeneron Study Site, Beaufort, South Carolina, 29902, United States|Regeneron Study Site, Ladson, South Carolina, 29456, United States|Regeneron Study Site, West Columbia, South Carolina, 29169, United States|Regeneron Study Site, Rapid City, South Dakota, 57701, United States|Regeneron Study Site, Germantown, Tennessee, 38138, United States|Regeneron Study Site, Knoxville, Tennessee, 37922, United States|Regeneron Study Site, Nashville, Tennessee, 37203, United States|Regeneron Study Site, Abilene, Texas, 79606, United States|Regeneron Study Site, Bellaire, Texas, 77401, United States|Regeneron Study Site 2, San Antonio, Texas, 78240, United States|Regeneron Study Site, The Woodlands, Texas, 77384, United States|Regeneron Study Site, Willow Park, Texas, 76087, United States|Regeneron Study Site 1, Salt Lake City, Utah, 84107, United States|Regeneron Study Site, Fairfax, Virginia, 22031, United States|Regeneron Study Site, Norfolk, Virginia, 23502, United States|Regeneron Study Site, Morgantown, West Virginia, 26506, United States|Regeneron Study Site, Calgary, Alberta, T2H 0C8, Canada|Regeneron Study Site, Mississauga, Ontario, L4W 1W9, Canada|Regeneron Study Site, North York, Ontario, M3C 0G9, Canada|Regeneron Study Site, Sherbrooke, Quebec, J1G 2V4, Canada|Regeneron Study Site, Pardubice, 530 02, Czechia|Regeneron Study Site, Prague 5, 150 00, Czechia|Regeneron Study Site, Praha 10, 100 34, Czechia|Regeneron Study Site, Praha 2, 128 08, Czechia|Regeneron Study Site, Neubrandenburg, Mecklenburg-Westfalen, 17036, Germany|Regeneron Study Site, Gottingen, Nordrhein-Westfalen, 37075, Germany|Regeneron Study Site, Munster, Nordrhein-Westfalen, 48145, Germany|Regeneron Study Site 1, Pecs, Baranya, H-7621, Hungary|Regeneron Study Site, Szombathely, Vas, H-9700, Hungary|Regeneron Study Site, Zalaegerszeg, Zala Megye, H-8900, Hungary|Regeneron Study Site, Budapest, H-1085, Hungary|Regeneron Study Site, Budapest, H-1106, Hungary|Regeneron Study Site, Budapest, H-1133, Hungary|Regeneron Study Site, Budapest, H-1145, Hungary|Regeneron Study Site, Debrecen, H-4032, Hungary|Regeneron Study Site, Szeged, H-6720, Hungary|Regeneron Study Site, Nagakute, Aichi, 480-1195, Japan|Regeneron Study Site, Nagoya, Aichi, 466-8560, Japan|Regeneron Study Site, Nagoya, Aichi, 467-8602, Japan|Regeneron Study Site, Yoshida-Gun, Fukui, 910-1193, Japan|Regeneron Study Site, Kurume, Fukuoka, 830-0011, Japan|Regeneron Study Site, Koriyama, Fukushima, 963-8052, Japan|Regeneron Study Site, Hakodate, Hokkaido, 041-0851, Japan|Regeneron Study Site, Kobe, Hyogo, 650-0017, Japan|Regeneron Study Site, Mito, Ibaraki, 310-0845, Japan|Regeneron Study Site, Toride, Ibaraki, 302-0014, Japan|Regeneron Study Site, Tsuchiura-shi, Ibaraki, 300-0817, Japan|Regeneron Study Site, Kita-gun, Kagawa, 761-0793, Japan|Regeneron Study Site, Kawasaki, Kanagawa, 216-8511, Japan|Regeneron Study Site, Matsumoto, Nagano, 390-8621, Japan|Regeneron Study Site, Nagasaki City, Nagasaki, 852-8501, Japan|Regeneron Study Site, Kashihara, Nara, 634-8522, Japan|Regeneron Study Site, Hirakata, Osaka, 573-1191, Japan|Regeneron Study Site, Tokorozawa, Saitama, 359-8513, Japan|Regeneron Study Site, Susono, Shizuoka, 410-1102, Japan|Regeneron Study Site, Chiyoda-ku, Tokyo, 101-8309, Japan|Regeneron Study Site, Hachioji, Tokyo, 193-0998, Japan|Regeneron Study Site, Itabashi-ku, Tokyo, 173-0015, Japan|Regeneron Study Site, Meguro-ku, Tokyo, 152-8902, Japan|Regeneron Study Site, Shimotsuke-shi, Totigi, 329-0498, Japan|Regeneron Study Site, Ube, Yamaguchi, 755-8505, Japan|Regeneron Study Site, Fukuoka, 812-0011, Japan|Regeneron Study Site, Fukuoka, 819-8585, Japan|Regeneron Study Site, Kagoshima, 890-8520, Japan|Regeneron Study Site, Osaka, 545-8586, Japan|Regeneron Study Site, Saitama, 330-8553, Japan|Regeneron Study Site, Tokushima, 770-8503, Japan|Regeneron Study Site, Arecibo, 00612, Puerto Rico|Regeneron Study Site, Sunderland, Tyne And Wear, SR2 9HP, United Kingdom|Regeneron Study Site, London, EC1V 2PD, United Kingdom
URL: https://clinicaltrials.gov/show/NCT04429503

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress