Study of the Effects of High Dose Aflibercept Injected Into the Eye of Patients With an Age-related Disorder That Causes Loss of Vision Due to Growth of Abnormal Blood Vessels at the Back of the Eye

Conditions

• Neovascular Age-Related Macular Degeneration

Eligibility Criteria

Sex

ALL

Age

50 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Aflibercept High Dose VEGF Trap-Eye (BAY86-5321) — DRUG
  Solution in Vial, intravitreal (IVT) injection
• Aflibercept VEGF Trap-Eye (Eylea, BAY86-5321) — DRUG
  Solution in Vial, 2 mg, intravitreal (IVT) injection

Study Details

In this study researchers want to learn more about changes in visual acuity (clarity of vision) with a high dose treatment with Aflibercept (Eylea) in patients suffering from neovascular age-related macular degeneration (nAMD). Neovascular AMD is an eye disease that causes blurred vision or a blind spot due to abnormal blood vessels that leak fluid or blood into the light sensitive lining inside the eye (retina). The fluid buildup causes the central part of the retina (macula) responsible for sharp, straight-ahead vision to swell and thicken (edema), which distorts vision.

Key Dates

Start date

Aug 11, 2020

Status verified

Aug 2025

Primary completion

Jul 27, 2022

Completion

Aug 7, 2024

Study Design

Enrollment

1,011 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Aflibercept 2q8
  In the double-masked study part (Years 1 and 2), Aflibercept 2 mg administered every 8 weeks after a loading phase. (Active Comparator) In Year 3, high dose aflibercept administered according to individual patient response. (Experimental)
• Experimental: Aflibercept HDq12
  Aflibercept high dose (HD) administered every 12 weeks after an initiation phase. Treatment intervals adjusted according to individual patient response.
• Experimental: Aflibercept HDq16
  Aflibercept high dose administered every 16 weeks after an initiation phase. Treatment intervals adjusted according to individual patient response.

Primary Outcome Measure

Change From Baseline in BCVA Measured by the ETDRS Letter Score at Week 48 [ Time Frame: At baseline and Week 48 ]

Locations (57)

Find similar trials in Phoenix, AZ

Related Studies

• Extension Study for the Port Delivery System With Ranibizumab (Portal)
  PHASE3 · Recruiting · Hoffmann-La Roche · Phoenix, Arizona
• Long-term Follow-Up Study of RGX-314 and Fellow Eye Substudy
  PHASE2 · Enrolling By Invitation · AbbVie · Phoenix, Arizona
• A Study Assessing Corneal Endothelial Cells in Participants With Neovascular Age-related Macular Degeneration (nAMD) Treated With the Port Delivery System With Ranibizumab (PDS)
  PHASE4 · Recruiting · Genentech, Inc. · Mesa, Arizona
• Home OCT-Guided Treatment Versus Treat and Extend for the Management of Neovascular AMD
  PHASE3 · Recruiting · Jaeb Center for Health Research · Glendale, California