Status:
COMPLETED
Long-Term Efficacy and Safety of Intravitreal Aflibercept Injections for the Treatment of Diabetic Retinopathy for Subjects Who Completed the 2-Year PANORAMA Trial
Lead Sponsor:
Greater Houston Retina Research
Collaborating Sponsors:
Regeneron Pharmaceuticals
Clinical Trials Resource Group, LLC
Conditions:
Diabetic Retinopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 tria...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2024
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT04708145
Start Date
June 1 2021
End Date
July 31 2024
Last Update
January 23 2025
Active Locations (14)
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1
Retina Vitreous Associates Medical Group
Beverly Hills, California, United States, 90211
2
Central Florida Retina Center
Orlando, Florida, United States, 32806
3
Center for Retina and Macular Disease
Winter Haven, Florida, United States, 33880
4
Marietta Eye Clinic
Marietta, Georgia, United States, 30060