check_circleStudy Completed
Central Retinal Vein Occlusion
Bayer Identifier:
17514
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Evaluation of a Treat and Extend regimen of intravitreal aflibercept for macular edema secondary to CRVO
Trial purpose
Central retinal vein occlusion (CRVO) occurs when the main blood vessel that transports blood away from the retina (the very back portion of the eye) becomes blocked, causing the leakage of fluid into the retina and thereby causing a swelling of the macula (the portion of the retina responsible for fine vision). This swelling is called macular edema. When the macula swells with fluid, central vision becomes blurry. The study drug aflibercept has been shown to reduce the amount of fluid and blood leaked into the retina. It can help to stabilize, and in many cases, improve the vision loss related to CRVO. Aflibercept has been approved for the treatment of macular edema secondary to CRVO in the United States (US), European Union (EU), Japan, and other countries.
The study was considered research because, although the study drug was already on the market for macular edema secondary to CRVO, there were no studies available that addressed the questions of what were useful intervals for treating and assessing patients, how did they differ among patients, and how were criteria applied for retreatment. The purpose of this study was to evaluate the effectiveness, treatment interval, and safety of the treatment regimen (pattern for administering treatment) in subjects with macular edema secondary to CRVO. In addition, this study explored new imaging methods for assessing the affected eye.
The study was considered research because, although the study drug was already on the market for macular edema secondary to CRVO, there were no studies available that addressed the questions of what were useful intervals for treating and assessing patients, how did they differ among patients, and how were criteria applied for retreatment. The purpose of this study was to evaluate the effectiveness, treatment interval, and safety of the treatment regimen (pattern for administering treatment) in subjects with macular edema secondary to CRVO. In addition, this study explored new imaging methods for assessing the affected eye.
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal
162Trial Dates
June 2016 - July 2019Phase
Phase 4Could I Receive a placebo
NoProducts
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Boisbriand, J7H 1S6, Canada | |
Completed | Göttingen, 37075, Germany | |
Completed | Heidelberg, 69120, Germany | |
Completed | Köln, 50935, Germany | |
Completed | Münster, 48149, Germany | |
Completed | London, N6A 4V2, Canada | |
Completed | Sherbrooke, J1G 2V4, Canada | |
Completed | Hamilton, L8G 5E4, Canada | |
Completed | Roma, 00133, Italy | |
Completed | Ancona, 60126, Italy | |
Completed | Milano, 20132, Italy | |
Completed | Barcelona, 08024, Spain | |
Completed | Barcelona, 08025, Spain | |
Completed | Oviedo, 33012, Spain | |
Completed | Calgary, T2H 0C8, Canada | |
Completed | Augsburg, 86156, Germany | |
Completed | Bristol, BS1 2LX, United Kingdom | |
Completed | Colchester, CO3 3NB, United Kingdom | |
Completed | Freiburg, 79106, Germany | |
Completed | Düsseldorf, 40225, Germany | |
Completed | Sant Cugat del Vallés, 08195, Spain | |
Completed | Roma, 00198, Italy | |
Completed | Padova, 35128, Italy | |
Completed | Milano, 20157, Italy | |
Completed | Bradford, BD9 6RJ, United Kingdom | |
Completed | Liverpool, L9 7AL, United Kingdom | |
Completed | Pisa, 56124, Italy | |
Completed | Parramatta, 2150, Australia | |
Completed | Sydney, 2000, Australia | |
Completed | BORDEAUX, 33076, France | |
Completed | Dijon Cedex, BP 1542-21, France | |
Completed | LYON, 69004, France | |
Completed | Oxford, OX3 9DU, United Kingdom | |
Withdrawn | Taunton, TA1 5DA, United Kingdom | |
Completed | Glostrup, 2600, Denmark | |
Withdrawn | München, 81675, Germany | |
Completed | Aalborg, 9100, Denmark | |
Completed | Albury, 2640, Australia | |
Completed | Quebec, G1V 1T6, Canada | |
Completed | Leipzig, 04103, Germany | |
Completed | Hannover, 30625, Germany | |
Completed | Karlsruhe, 76133, Germany | |
Withdrawn | Düsseldorf, 40212, Germany | |
Withdrawn | Siegburg, 53721, Germany | |
Completed | Sunderland, SR2 9HP, United Kingdom | |
Withdrawn | London, NW1 5QH, United Kingdom | |
Completed | Viladecans, 08840, Spain | |
Withdrawn | Madrid, 28046, Spain |
Primary Outcome
- The proportion of participants who gained ≥ 15 letters in best corrected visual acuity (BCVA) on the early treatment diabetic retinopathy score (ETDRS) chart compared to baselineParticipants who completed the study with a gain of ≥ 15 letters or dropped the study after Week 24 and having a permanent resolution of macular edema and a gain of ≥ 15 letters from baseline with regard to the latest BCVA assessment. The ETDRS chart includes 70 letters in total, more letters read correctly represents a better visual acuity.date_rangeTime Frame:Baseline, Week 24 and Week 76
- The proportion of participants with a mean treatment interval between injections of ≥ 8 weeksParticipants who completed the study with a mean treatment interval between injections of ≥ 8 weeks or dropped out of the study after Week 24 and having a permanent resolution of macular edemadate_rangeTime Frame:From the last actual visit of the initiation phase to Week 76
Secondary Outcome
- The mean treatment interval between injectionsdate_rangeTime Frame:From baseline to Week 76
- The change in best corrected visual acuity (BCVA) as measured by the early treatment diabetic retinopathy letter score (ETDRS) from baselineThe 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:Baseline and Week 24, 52, and 76
- The change in central retinal thickness (CRT) from baselineCRT was measured in the study eye by spectral domain optical coherence tomography (SD-OCT).date_rangeTime Frame:Baseline and Week 24, 52 and 76
- The number of injections per participantdate_rangeTime Frame:From baseline to Week 76
- The proportion of participants who gain ≥ 15 letters in best corrected visual acuity (BCVA) on the early treatment diabetic retinopathy score (ETDRS) chart compared to baselineThe ETDRS chart includes 70 letters in total. More letters read correctly represents a better visual acuitydate_rangeTime Frame:Baseline and Week 24, Week 52
- The proportion of participants with change in retinal non-perfusion (FA/FP) status from baselineThe change in retinal non-perfusion status by fundus angiography (FA)/fundus photography (FP)-confirmed ischemic disc area. The status was categorized into: no non-perfusion, <10 ischemic disc area, >=10 ischemic disc area and missing statusdate_rangeTime Frame:Baseline and Week 24, 52 and 76
- The proportion of participants with absence of subretinal fluiddate_rangeTime Frame:Baseline, week 24, week 52 and week 76
- Incidence and severity of ocular treatment-emergent adverse eventsdate_rangeTime Frame:Up to 30 days after week 76
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
N/ABlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1