Study 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

Inclusion Criteria
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
Exclusion Criteria
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

Products

Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)

Accepts Healthy Volunteer

Where 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 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.
Time Frame:
From baseline to Week 52
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).
Time Frame:
From baseline to week 52
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
Time Frame:
From baseline to week 52
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.
Time Frame:
From baseline to Week 100
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).
Time Frame:
From baseline to Week 100
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
Time Frame:
From baseline to Week 100
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
Time Frame:
Up to Week 100
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

Additional Information

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