Macular edema secondary to CRVO MedDRA version: 20.0 Level: PT Classification code 10025415 Term: Macular oedema System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Trade Name: Eylea
Product Name: Aflibercept
Pharmaceutical Form: Solution for injection
INN or Proposed INN: AFLIBERCEPT
CAS Number: 862111-32-8
Current Sponsor code: BAY 86-5321
Other descriptive nam
Sponsors
Bayer AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Center-involved macular edema secondary to CRVO for no longer than 3 months (at the screening visit it should be ensured that the subjects will comply with the criterion of = 3 months since onset of macular edema at their scheduled baseline visit). - Adult subjects diagnosed with macular edema secondary to CRVO who are scheduled to be treated with IVT aflibercept as per investigator's routine treatment practice with the intent to use a T&E regimen after initial dosing. - Treatment-naïve subjects for macular edema secondary to CRVO. - Men and women = 18 years of age. - Documented BCVA of ETDRS letter score of 73 to 24 letters (Snellen equivalent of 20/40 to 20/320) in the study eye. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 32 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 128
Exclusion criteria
Exclusion criteria: - Previous PRP or macular laser photocoagulation in the study eye. - Any prior or concomitant ocular treatment (e.g. anti-VEGF therapy, corticosteroids) in the study eye for macular edema secondary to RVO, except dietary supplements or vitamins prior to inclusion in the study. Intraocular anti-VEGF treatment is permitted for the treatment of diseases of fellow eye except for those that are specifically excluded. - Prior systemic anti-VEGF or corticosteroid therapy, investigational or approved, within the last 3 months before the first dose in the study. - Previous use of intraocular corticosteroids in the study eye at any time or use of periocular corticosteroids in the study eye within 12 months prior to Day 1. - Any active intraocular, extraocular, and periocular inflammation or infection in either eye within 4 weeks of screening. - Any history of allergy to povidone iodine. - Known serious allergy to the fluorescein sodium for injection in angiography. - Presence of any contraindications indicated in the EU commission/locally approved label for IVT aflibercept: hypersensitivity to the active substance IVT aflibercept or to any of the excipients; active or suspected ocular or periocular infection; active severe intraocular inflammation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the efficacy and durability (treatment interval) of 2 mg IVT aflibercept in a T&E regimen over a treatment period of 76 weeks using protocol defined visual and anatomic criteria in subjects with macular edema secondary to CRVO;Secondary Objective: To assess the efficacy of IVT aflibercept as measured by visual acuity and anatomic outcomes using spectral domain optical coherence tomography (SD OCT), and perfusion status using FA/fundus photography (FP) and also to assess T&E applied posology of IVT aflibercept (number of injections, length of injection interval) ;Primary end point(s): 1) The proportion of subjects who gain = 15 letters in best corrected visual acuity on the early treatment diabetic retinopathy score chart. 2) The proportion of subjects with a mean treatment interval between injections of = 8 weeks;Timepoint(s) of evaluation of this end point: 1) Compared with baseline at Week 76 2) From the last actual visit of the initiation phase to Week 76 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) The change in best corrected visual acuity as measured by the early treatment diabetic retinopathy letter score 2) The change in central retinal thickness 3) The number of injections 4) The mean treatment interval between injections 5) The proportion of subjects who gain = 15 letters in best corrected visual acuity on the early treatment diabetic retinopathy chart 6) The change in retinal perfusion (FA/FP) status 7) The proportion of subjects with absence of fluid;Timepoint(s) of evaluation of this end point: 1) From baseline to Weeks 24, 52, and 76 2) From baseline to Weeks 24, 52, and 76 3) From baseline to Week 76 4) From baseline to Week 76 5) Compared with baseline at Weeks 24 and 52 6) From baseline to Weeks 24, 52 and 76 7) At Weeks 24, 52, and 76 | — |
Countries
Australia, Canada, Denmark, France, Germany, Italy, Spain, United Kingdom
Contacts
Public ContactClinical Trials Contact, CTP EU CTR
Bayer AG
Outcome results
None listed