Long-Term Efficacy and Safety of Intravitreal Aflibercept Injections for the Treatment of Diabetic Retinopathy for Subjects Who Completed the 2-Year PANORAMA Trial

Completed · Phase 4

Conditions studied: Diabetic Retinopathy

In brief

The VOYAGE trial will assess diabetic retinopathy severity scale (DRSS) levels, through 112 weeks, while being managed with aflibercept as needed, among subjects who completed the 2-year PANORAMA trial (VGFTe-OD-1411) and were treated in a clinical setting prior to joining the VOYAGE study.

Key facts

Study ID

NCT04708145

Run by

Greater Houston Retina Research

People needed

41

Starts

2021-06-01

Expected to finish

2024-07-31

Last updated by the study team

2025-01-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Enrolled and completed PANORAMA (VGFTe-OD-1411) clinical trial
• Willing and able to comply with clinic visits and study-related procedures
• Provide signed informed consent

You may not qualify if…

• Any prior systemic anti-vascular endothelial growth factor (VEGF) treatment or IVT anti-VEGF treatment in the study eye within 21 days of baseline
• Any intra- or periocular corticosteroid treatment in the study eye within 3 months of baseline
• Any intraocular sustained-release treatment, implantable device, or gene therapy in the study eye
• Pregnant or breastfeeding women
• Sexually active men* or women of childbearing potential** who are unwilling to practice adequate contraception during the study (adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening/baseline; intrauterine device (IUD); bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly).
• Contraception is not required for men with documented vasectomy. **Postmenopausal women must be amenorrhoeic for at least 12 months in order not to be considered of childbearing potential. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.

Where it is running

• Retina Vitreous Associates Medical Group — Beverly Hills, California, United States
• Central Florida Retina Center — Orlando, Florida, United States
• Center for Retina and Macular Disease — Winter Haven, Florida, United States
• Marietta Eye Clinic — Marietta, Georgia, United States
• John Kenyon American Eye Institute — New Albany, Indiana, United States
• Cumberland Valley Retina Consultants, P.C. — Hagerstown, Maryland, United States
• Dean McGee Eye Institute — Oklahoma City, Oklahoma, United States
• Palmetto Retina Center, LLC - Florence — Florence, South Carolina, United States
• Palmetto Retina Center — West Columbia, South Carolina, United States
• Charles Retina Institute — Germantown, Tennessee, United States
• Retina Consultants of Texas — Bellaire, Texas, United States
• Valley Retina Institute — Harlingen, Texas, United States
• Strategic Clinical Research Group, LLC — Willow Park, Texas, United States
• Emanuelli Research and Development Center, LLC — Arecibo, Puerto Rico

Full record on ClinicalTrials.gov

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