check_circleStudy Completed
Macular edema
Bayer Identifier:
17613
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Efficacy and safety of three different aflibercept regimens in subjects with diabetic macular edema (DME)
Trial purpose
To evaluate the efficacy of long-term treatment with 2 mg aflibercept via different intravitreal (IVT) treatment regimens to participants with DME pretreated with 2 mg aflibercept every 8 weeks after 5 initial monthly injections for approximately 1 year or more (according to the EU label for the first year of treatment)
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal
463Trial Dates
November 2016 - September 2019Phase
Phase 3Could I Receive a placebo
NoProducts
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Darmstadt, 64297, Germany | |
Completed | Köln, 50924, Germany | |
Completed | Göttingen, 37075, Germany | |
Completed | Frankfurt, 60596, Germany | |
Completed | Dresden, 01307, Germany | |
Withdrawn | Leipzig, 04103, Germany | |
Completed | Bonn, 53105, Germany | |
Completed | Marburg, 35043, Germany | |
Completed | Sherbrooke, J1G 2V4, Canada | |
Completed | Montreal, H4P 2S4, Canada | |
Completed | Halifax, B3H 2Y9, Canada | |
Completed | Toronto, M3C 0G9, Canada | |
Completed | Mississauga, L4W 1W9, Canada | |
Completed | Wien, 1090, Austria | |
Completed | Graz, 8036, Austria | |
Completed | CRETEIL CEDEX, 94010, France | |
Completed | Praha 10, 100 34, Czech Republic | |
Completed | Hradec Kralove, 500 05, Czech Republic | |
Completed | Southampton, SO16 6YD, United Kingdom | |
Completed | Sunderland, SR2 9HP, United Kingdom | |
Completed | Leeds, LS9 7TF, United Kingdom | |
Completed | London, EC1V 2PD, United Kingdom | |
Completed | Gdansk, 80-809, Poland | |
Completed | Lublin, 20-081, Poland | |
Completed | Krakow, 31-501, Poland | |
Completed | Bydgoszcz, 85-631, Poland | |
Completed | Warszawa, 01-013, Poland | |
Completed | Poznan, 61-285, Poland | |
Completed | Warszawa, 04-141, Poland | |
Completed | Lodz, 91-134, Poland | |
Completed | Katowice, 40-594, Poland | |
Completed | Genova, 16132, Italy | |
Completed | Sassari, 07100, Italy | |
Completed | Torino, 10122, Italy | |
Completed | Roma, 00133, Italy | |
Completed | Milano, 20122, Italy | |
Completed | Firenze, 50134, Italy | |
Completed | Milano, 20132, Italy | |
Completed | Cagliari, 09124, Italy | |
Completed | Padova, 35128, Italy | |
Completed | Barcelona, 08036, Spain | |
Completed | L'Hospitalet de Llobregat, 08907, Spain | |
Completed | Barcelona, 08035, Spain | |
Completed | Albacete, 02006, Spain | |
Completed | Valencia, 46014, Spain | |
Completed | Sant Cugat del Vallés, 08195, Spain | |
Completed | Leiria, 2410-197, Portugal | |
Completed | Lisboa, 1649-035, Portugal | |
Completed | Vila Franca de Xira, 2600-178, Portugal | |
Completed | Coimbra, 3000-548, Portugal | |
Completed | Porto, 4200-319, Portugal | |
Completed | Budapest, 1085, Hungary | |
Completed | Budapest, 1133, Hungary | |
Completed | Debrecen, 4032, Hungary | |
Completed | Pecs, 7621, Hungary | |
Completed | Budapest, 1106, Hungary | |
Completed | Zvolen, 960 01, Slovakia | |
Completed | Bratislava, 851 07, Slovakia | |
Completed | Nitra, 949 01, Slovakia | |
Completed | Bratislava, 826 06, Slovakia | |
Completed | Zilina, 01207, Slovakia | |
Completed | Kaunas, LT-50009, Lithuania | |
Completed | Vilnius, LT-08661, Lithuania | |
Completed | Bern, Switzerland | |
Completed | Genève, 1204, Switzerland |
Primary Outcome
- Mean change from baseline in Best Corrected Visual Acuity (BCVA) at Week 52Best Corrected Visual Acuity (BCVA) was measured in the study eye by the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score starting at 4 meters. The ETDRS chart includes 70 letters in total and the letter score ranges from 0 to 100. More letters read correctly results in a higher letter score, which represents better visual acuity.date_rangeTime Frame:From baseline to Week 52enhanced_encryptionNoSafety Issue:
Secondary Outcome
- Mean change from baseline in Central Retinal Thickness (CRT) at Week 52Central Retinal Thickness (CRT) was measured in the study eye by spectral domain optical coherence tomography (SD-OCT).date_rangeTime Frame:From baseline to week 52enhanced_encryptionNoSafety Issue:
- Number of participants with categorized changes from baseline in Best Corrected Visual Acuity (BCVA) at Week 52Best Corrected Visual Acuity (BCVA) was measured in the study eye by the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score starting at 4 meters. The ETDRS chart includes 70 letters in total and the letter score ranges from 0 to 100. More letters read correctly results in a higher letter score, which represents better visual acuitydate_rangeTime Frame:From baseline to week 52enhanced_encryptionNoSafety Issue:
- Mean change from baseline in Best Corrected Visual Acuity (BCVA) at Week 100Best Corrected Visual Acuity (BCVA) was measured in the study eye by the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score starting at 4 meters. The ETDRS chart includes 70 letters in total and the letter score ranges from 0 to 100. More letters read correctly results in a higher letter score, which represents better visual acuity.date_rangeTime Frame:From baseline to Week 100enhanced_encryptionNoSafety Issue:
- Mean change from baseline in Central Retinal Thickness (CRT) at Week 100Central Retinal Thickness (CRT) was measured in the study eye by spectral domain optical coherence tomography (SD-OCT).date_rangeTime Frame:From baseline to Week 100enhanced_encryptionNoSafety Issue:
- Number of participants with categorized changes from baseline in Best Corrected Visual Acuity (BCVA) at Week 100Best Corrected Visual Acuity (BCVA) was measured in the study eye by the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score starting at 4 meters. The ETDRS chart includes 70 letters in total and the letter score ranges from 0 to 100. More letters read correctly results in a higher letter score, which represents better visual acuitydate_rangeTime Frame:From baseline to Week 100enhanced_encryptionNoSafety Issue:
- Number of participants with treatment-emergent adverse event (TEAE)AEs that started after the first application of aflibercept under this protocol until 30 days after the last dose of study drug administrationdate_rangeTime Frame:Up to Week 100enhanced_encryptionYesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Open LabelAssignment
Parallel AssignmentTrial Arms
3