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

Launched by GREATER HOUSTON RETINA RESEARCH · Jan 12, 2021

Keywords

ClinConnect Summary

This phase 4 study is designed to assess the need for ongoing 2 mg intravitreal aflibercept injections (IAI) for subjects who completed the 2-year PANORAMA (VGFTe-OD-1411) trial for the management of diabetic retinopathy (DR). Sites will be considered for VOYAGE if they have 4 or more subjects from PANORAMA able to participate.

Relevant data from all participating subjects will be collected and reported retrospectively for the period between PANORAMA study exit and VOYAGE study enrollment.

For the prospective portion of the study, eyes will be assigned to 1 of 2 groups, eyes without panre...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Enrolled and completed PANORAMA (VGFTe-OD-1411) clinical trial
• • 2. Willing and able to comply with clinic visits and study-related procedures
• • 3. Provide signed informed consent
• Exclusion Criteria:
• • 1. Any prior systemic anti-vascular endothelial growth factor (VEGF) treatment or IVT anti-VEGF treatment in the study eye within 21 days of baseline
• • 2. Any intra- or periocular corticosteroid treatment in the study eye within 3 months of baseline
• • 3. Any intraocular sustained-release treatment, implantable device, or gene therapy in the study eye
• • 4. Pregnant or breastfeeding women
• • 5. 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.