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

Part of paid clinical trials in Beverly Hills, California.

Sponsor
Greater Houston Retina Research
Study ID
NCT04708145
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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 Dates

Start date
Jun 1, 2021
Status verified
Jan 2025
Primary completion
Jul 31, 2024
Completion
Jul 31, 2024

Study Design

Enrollment
41 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1
    Study eyes without PRP from the PANORAMA trial. Subjects will be evaluated every 16 weeks and treated if DRSS level is 47 or worse as determined by the treating investigator. Subjects may be evaluated every 8 weeks if a 2-step DRSS level worsening compared to the last protocol-scheduled 16-week visit occurs, the DRSS level is 53 or worse, or if a subject has active PDR. Visits can continue every 8 weeks until there is no active PDR, and the DRSS improves to the level observed at the visit before the subject began being seen at 8-week intervals. Thereafter, visits will continue at 16 week intervals.
  • Experimental: Group 2
    Study eyes with PRP from the PANORAMA trial. Subjects will be evaluated every 16 weeks and treated if the neovascular disease process is active and stable (not new or worse) as determined by the treating investigator. If the neovascular disease is inactive, no treatment will be given. If new or worsening neovascularization develops, subjects may be seen and treated every 8 weeks until the neovascular disease is stable or inactive, at which time the interval between visits will increase to 16 weeks.

Primary Outcome Measure

DRSS Level Achievement in the VOYAGE study [ Time Frame: 112 weeks ]

Locations (13)

FacilityCityStateZIPSite coordinators
Retina Vitreous Associates Medical GroupBeverly HillsCalifornia90211-
Central Florida Retina CenterOrlandoFlorida32806-
Center for Retina and Macular DiseaseWinter HavenFlorida33880-
Marietta Eye ClinicMariettaGeorgia30060-
John Kenyon American Eye InstituteNew AlbanyIndiana47150-
Cumberland Valley Retina Consultants, P.C.HagerstownMaryland21740-
Dean McGee Eye InstituteOklahoma CityOklahoma73104-
Palmetto Retina Center, LLC - FlorenceFlorenceSouth Carolina29501-
Palmetto Retina CenterWest ColumbiaSouth Carolina29169-
Charles Retina InstituteGermantownTennessee38138-
Retina Consultants of TexasBellaireTexas77401-
Valley Retina InstituteHarlingenTexas78550-
Strategic Clinical Research Group, LLCWillow ParkTexas76087-

Find similar trials in Beverly Hills, CA

By condition
Diabetic retinopathy
By specialty
OphthalmologyRetina
By research site
Retina Vitreous Associates Medical Group· Beverly Hills, CACentral Florida Retina Center· Orlando, FLCenter for Retina and Macular Disease· Winter Haven, FLMarietta Eye Clinic· Marietta, GAJohn Kenyon American Eye Institute· New Albany, INCumberland Valley Retina Consultants, P.C.· Hagerstown, MD

Related Studies