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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
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

Full criteria on ClinicalTrials.gov

Sites (14)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Emanuelli Research and Development Center, LLC
Coordinator of this site? Confirm its status
AreciboPuerto RicoUnknown status
Retina Consultants of Texas
Coordinator of this site? Confirm its status
BellaireUnited StatesUnknown status
Retina-Vitreous Associates Medical Group
Coordinator of this site? Confirm its status
Beverly HillsUnited StatesUnknown status
Palmetto Retina Center, LLC - Florence
Coordinator of this site? Confirm its status
FlorenceUnited StatesUnknown status
Charles Retina Institute
Coordinator of this site? Confirm its status
GermantownUnited StatesUnknown status
Cumberland Valley Retina Consultants,P.C.
Coordinator of this site? Confirm its status
HagerstownUnited StatesUnknown status
Valley Retina Institute
Coordinator of this site? Confirm its status
HarlingenUnited StatesUnknown status
Marietta Eye Clinic
Coordinator of this site? Confirm its status
MariettaUnited StatesUnknown status
John Kenyon American Eye Institute
Coordinator of this site? Confirm its status
New AlbanyUnited StatesUnknown status
Dean McGee Eye Institute
Coordinator of this site? Confirm its status
Oklahoma CityUnited StatesUnknown status
Central Florida Retina Center
Coordinator of this site? Confirm its status
OrlandoUnited StatesUnknown status
Palmetto Retina Center
Coordinator of this site? Confirm its status
West ColumbiaUnited StatesUnknown status
Strategic Clinical Research Group, LLC
Coordinator of this site? Confirm its status
Willow ParkUnited StatesUnknown status
Center for Retina and Macular Disease
Coordinator of this site? Confirm its status
Winter HavenUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.