Evaluation of Treatment of High riSk proLiferative Diabetic retinopathY With Intravitreal Aflibercept Injection (ELYSIAN)
Overview
- Phase
- Phase 2
- Intervention
- Aflibercept
- Conditions
- Proliferative Diabetic Retinopathy
- Sponsor
- Valley Retina Institute
- Enrollment
- 30
- Primary Endpoint
- Assess ocular and non-ocular adverse events
- Last Updated
- 10 years ago
Overview
Brief Summary
To assess the safety and efficacy of intravitreal aflibercept injection in the regression of retinal neovascularization secondary to high-risk PDR.
To characterize baseline/post-induction/maintenance levels of proinflammatory mediators in patients with high-risk PDR
Detailed Description
This study will evaluate two dosing regimens (monthly and PRN following a loading dose) for treatment of PDR with intravitreal aflibercept injection. Additionally, the study will identify biomarker mediators in vitreous fluid present at baseline in patients with PDR and will track over the course of a year their profile changes in response to these two dosing regimens. The treatment regimens will provide information on the biomarker profile with a monthly regimen as well as with a variable regimen. Furthermore, biomarker mediators that may be associated with anti-VEGF responders and non-responders may also be identified. 105 biomarker mediators (cytokines/chemokines) which have been identified as playing a role in PDR in published studies will be profiled in patients with PDR.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Eligible eyes will have active PDR with high risk characteristics (HRC) as defined by the DRS. All eyes must meet at least one or both of the following criteria:
- •Any neovascularization of the disc (NVD) + vitreous hemorrhage
- •Mild neovascularization of the disc (NVD) of at least 1/2 to 1/3 disc area as shown in standard photograph 10A of the DRS
- •Moderate neovascularization of the retina elsewhere (NVE) of at least 1/2 disc area as shown in standard photograph 7 of the DRS + vitreous hemorrhage
- •Patient's study eye must be treatment naïve; no history of intravitreal anti-angiogenic treatment, intravitreal steroid treatment, or any laser treatment to study eye
- •18 years or older males and females with a history of diabetes mellitus and ability to sign informed consent
- •ETDRS visual acuity score greater than or equal to 24 letters (approximately 20/320) and less than or equal to 85 letters (approximately 20/20) by the ETDRS visual acuity protocol at the screening visit
- •Eyes with mild pre-retinal hemorrhage or mild vitreous hemorrhage that does not interfere with clear visualization of the macula and optic disc are eligible for this study
Exclusion Criteria
- •Subjects who meet any of the following criteria will be excluded from this study:
- •Presence of moderate or dense PRH or VH that prevents clear visualization of the macula and/or optic disc
- •Presence of either:
- •Significant epiretinal membranes involving the macula, or
- •Proliferative diabetic membranes along the major retinal arcades that are extensive enough to cause either:
- •Significant vitreomacular traction or
- •Significant impairment in visual acuity
- •Presence of any tractional retinal detachment
- •Severe ischemia involving the foveal avascular zone (≥1 disc area) as determined by fluorescein angiography performed at the initial screening visit
- •Significant media opacity (due to cornea, anterior chamber, or lens) precluding clear visualization of the macula or optic disc
Arms & Interventions
Arm 1
1:1 Intravitreal Aflibercept Injection once every 4 weeks
Intervention: Aflibercept
Arm 2
Intravitreal of Aflibercept once every 4 weeks for 4 months then as needed (PRN)
Intervention: Aflibercept
Outcomes
Primary Outcomes
Assess ocular and non-ocular adverse events
Time Frame: 12 Months