Evaluation of Treatment of High riSk proLiferative Diabetic retinopathY With Intravitreal Aflibercept injectioN

NCT02630277 | Unknown Phase 2

• 1 other identifier: ELYSIAN
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Conditions

Proliferative Diabetic Retinopathy

Keywords

Proliferative Diabetic Retinopathy; High Risk PDR; aflibercept; regression of retinal neovascularization

Outcome Measures

Primary Outcomes (1)

• Assess ocular and non-ocular adverse events

  12 Months

Study Arms (2)

Arm 1

EXPERIMENTAL

1:1 Intravitreal Aflibercept Injection once every 4 weeks

Drug: Aflibercept

Arm 2

EXPERIMENTAL

Intravitreal of Aflibercept once every 4 weeks for 4 months then as needed (PRN)

Drug: Aflibercept

Interventions

Aflibercept DRUG

Intravitreal Aflibercept Injection 2.0 mg

Also known as: Eylea

Arm 1; Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 hemorrhage2. 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
• 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

You may not qualify if:

• 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
• Presence of neovascular glaucoma with or without hyphema
• Previous treatment with intravitreal steroid injections in the study eye
• Previous treatment with topical anti-inflammatory medications in the study eye
• Previous treatment with peribulbar steroid injections in the study eye
• Previous PRP/focal laser treatment in the study eye

Sponsors & Collaborators

• Valley Retina Institute: lead

MeSH Terms

Interventions

aflibercept

Study Officials

• Victor H Gonzalez, MD

  Medical Director

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Victor H. Gonzalez, MD

CONTACT

956-631-8875; research@vritx.com

Yesenia Salinas, MA

CONTACT

956-631-8875; ysalinas@vritx.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2015
• First Posted: December 15, 2015
• Study Start: January 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: June 1, 2017
• Last Updated: December 15, 2015

Record last verified: 2015-12