Evaluation of a Treat and Extend regimen of intravitreal aflibercept for macular edema secondary to CRVO
- Conditions
- Macular edema secondary to CRVOMedDRA version: 20.0Level: PTClassification code 10025415Term: Macular oedemaSystem Organ Class: 10015919 - Eye disordersTherapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2014-003193-17-DE
- Lead Sponsor
- Bayer AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 160
- 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
- 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br><br>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<br><br>2) From the last actual visit of the initiation phase to Week 76
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1) The change in best corrected visual acuity as measured by the early treatment diabetic retinopathy letter score<br>2) The change in central retinal thickness<br>3) The number of injections<br>4) The mean treatment interval between injections<br>5) The proportion of subjects who gain = 15 letters in best corrected visual acuity on the early treatment diabetic retinopathy chart<br>6) The change in retinal perfusion (FA/FP) status<br>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<br>2) From baseline to Weeks 24, 52, and 76<br>3) From baseline to Week 76<br>4) From baseline to Week 76<br>5) Compared with baseline at Weeks 24 and 52<br>6) From baseline to Weeks 24, 52 and 76<br>7) At Weeks 24, 52, and 76