NCT04708145CompletedPhase 4
Long-Term Efficacy and Safety of Intravitreal Aflibercept Injections for the Treatment of Diabetic Retinopathy for Subjects Who Completed the 2-Year PANORAMA Trial
Source: ClinicalTrials.gov · Last updated 23 Jan 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 41 (actual)
- First submitted
- 6 Jan 2021
- Start date
- 1 Jun 2021
- Primary completion date
- 31 Jul 2024
- Lead sponsor
- Greater Houston Retina Research
- Diseases
- Diabetic eye disease
- NCT number
- NCT04708145
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 41
- From 1 Jun 2021 to the primary completion date, 31 Jul 2024
- 14 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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.
Other
- Pregnant or breastfeeding women
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (14)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Emanuelli Research and Development Center, LLC Coordinator of this site? Confirm its status | Arecibo | Puerto Rico | Unknown status |
| Retina Consultants of Texas Coordinator of this site? Confirm its status | Bellaire | United States | Unknown status |
| Retina-Vitreous Associates Medical Group Coordinator of this site? Confirm its status | Beverly Hills | United States | Unknown status |
| Palmetto Retina Center, LLC - Florence Coordinator of this site? Confirm its status | Florence | United States | Unknown status |
| Charles Retina Institute Coordinator of this site? Confirm its status | Germantown | United States | Unknown status |
| Cumberland Valley Retina Consultants,P.C. Coordinator of this site? Confirm its status | Hagerstown | United States | Unknown status |
| Valley Retina Institute Coordinator of this site? Confirm its status | Harlingen | United States | Unknown status |
| Marietta Eye Clinic Coordinator of this site? Confirm its status | Marietta | United States | Unknown status |
| John Kenyon American Eye Institute Coordinator of this site? Confirm its status | New Albany | United States | Unknown status |
| Dean McGee Eye Institute Coordinator of this site? Confirm its status | Oklahoma City | United States | Unknown status |
| Central Florida Retina Center Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Palmetto Retina Center Coordinator of this site? Confirm its status | West Columbia | United States | Unknown status |
| Strategic Clinical Research Group, LLC Coordinator of this site? Confirm its status | Willow Park | United States | Unknown status |
| Center for Retina and Macular Disease Coordinator of this site? Confirm its status | Winter Haven | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.