check_circleStudy Completed

Macular edema

Bayer Identifier:
17613
ClinicalTrials.gov Identifier:
NCT02818998
EudraCT Number:
2014-004938-25
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

Both

Age

18 - N/A
  • The subject’s history of aflibercept treatment met all of the following:
    - Treatment in the study eye was initiated with five monthly (-1 week /+2 weeks) doses of 2 mg aflibercept and improvements of visual and anatomic outcomes were observed and documented.
    - Following the above initiation phase, the intervals between treatments were between 6 weeks and 12 weeks (one exception was allowed).
    - The interval between the last 2 pre-study injections was ≥ 8 weeks, and visual and anatomic outcomes had been stable over this interval.
    - The subject received the last intravitreal (IVT) injection of aflibercept in the study eye 8 weeks (±10 days) before the first planned treatment /randomization in this study.
    - Total prior treatment duration with aflibercept (i.e. from first aflibercept treatment ever to enrollment into this study) was 1 year or longer.

    To be met at initiation of pre-study aflibercept treatment:
    - Type 1 or 2 diabetes mellitus (DM)
    - Diagnosis of diabetic macular edema (DME) secondary to DM involving the center of the macula (defined as the area of the center subfield on optical coherence tomography [OCT]) in the study eye
    - Decrease in vision determined to be primarily the result of DME in the study eye
    - Best corrected visual acuity (BCVA) in the study eye of Early Treatment Diabetic Retinopathy Study (ETDRS) letter score 73 to 24
  • At initiation of pre-study aflibercept treatment:
    - Previous treatment with anti-angiogenic drugs in study eye (e.g., pegaptanib sodium, bevacizumab, ranibizumab, or aflibercept) within the last 12 weeks before initiation of aflibercept pre-study treatment

    At initiation of pre-study aflibercept treatment, screening for this study, and baseline for this study:
    - Prior treatment of the study eye with long acting steroids, either periocular or intraocular, in the preceding 120 days or Iluvien intravitreal implant at any time
    - Active proliferative diabetic retinopathy, current iris neovascularization, vitreous hemorrhage, or tractional retinal detachment in the study eye
    - Cataract surgery or any other intraocular surgery within 90 days of aflibercept treatment in the study eye
    - Ocular inflammation (including trace or above) or history of uveitis in the study eye
    - Structural damage to the center of the macula in the study eye that was likely to preclude improvement in BCVA following the resolution of macular edema including atrophy of the retinal pigment epithelium, subretinal fibrosis or scar, significant macular ischemia or organized hard exudates
    - Concurrent disease in the study eye, other than DME, that could compromise visual acuity, require medical or surgical intervention during the study period, or could confound interpretation of the results (including advanced glaucoma, retinal vascular occlusion, retinal detachment, macular hole, or choroidal neovascularization of any cause)
    - Uncontrolled DM as defined by hemoglobin (Hb) A1c > 12.0% at screening and baseline for this study
    - Any ocular or periocular infection in the preceding 4 weeks in either eye
    - History of either cerebral vascular accident and/or myocardial infarction within 180 days before aflibercept treatment

Trial summary

Enrollment Goal
463
Trial Dates
November 2016 - September 2019
Phase
Phase 3
Could I Receive a placebo
No
Products
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
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 52
    Best 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 52
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Mean change from baseline in Central Retinal Thickness (CRT) at Week 52
    Central Retinal Thickness (CRT) was measured in the study eye by spectral domain optical coherence tomography (SD-OCT).
    date_rangeTime Frame:
    From baseline to week 52
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with categorized changes from baseline in Best Corrected Visual Acuity (BCVA) at Week 52
    Best 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 52
    enhanced_encryption
    Safety Issue:
    No
  • Mean change from baseline in Best Corrected Visual Acuity (BCVA) at Week 100
    Best 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 100
    enhanced_encryption
    Safety Issue:
    No
  • Mean change from baseline in Central Retinal Thickness (CRT) at Week 100
    Central Retinal Thickness (CRT) was measured in the study eye by spectral domain optical coherence tomography (SD-OCT).
    date_rangeTime Frame:
    From baseline to Week 100
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with categorized changes from baseline in Best Corrected Visual Acuity (BCVA) at Week 100
    Best 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 100
    enhanced_encryption
    Safety Issue:
    No
  • 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 administration
    date_rangeTime Frame:
    Up to Week 100
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

An open-label, randomized, active-controlled, parallel-group, Phase-3b study of the efficacy, safety, and tolerability of three different treatment regimens of 2 mg aflibercept administered by intravitreal injections to subjects with diabetic macular edema (DME)
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
3

Additional Information

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