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.

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

Diabetic Retinopathy

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 panretinal photocoagulation (PRP) and eyes with PRP.

      Group 1: Subjects with study eyes without PRP will be seen every 16 weeks (Q16W) and treated
      with IAI on a flexible treatment regimen based on their DRSS level. An injection will be
      given at each 16-week visit when the DRSS level is 47 or worse. If the DRSS level is better
      than 47, for example level 43 or 35, the study eye will not be treated. DRSS level will be
      determined by the investigator, based on ophthalmic exam and fundus photography (FP) compared
      to prior imaging when available.

      Every 8 week visits can be performed under specific circumstances:

        -  If a subject has a 2-step DRSS level worsening compared to the last protocol-scheduled
           16-week visit (for example the week-16 or week-32 visit) and/or the DRSS level is 53 or
           worse OR

        -  If a subject has active proliferative DR (PDR)

      Under both of these circumstances, IAI will be administered as scheduled and the subject can
      be seen and treated every 8 weeks (Q8W) with IAI. Under both of these circumstances, Q8W
      visits and Q8W IAI treatments can be continued 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.

      Group 2: Subjects with study eyes with PRP will be seen Q16W and treated with IAI on a
      flexible treatment regimen based on activity of the neovascular disease process as assessed
      by the treating investigator based on ophthalmic exam and/or FP compared to prior imaging
      when available. If the neovascular disease is inactive, no treatment will be given. If the
      neovascular disease is active and stable (not new or worse), the subject will be treated with
      intravitreal (IVT) IAI at the Q16W interval. If new or worsening neovascular disease
      develops, subjects may be seen and treated Q8W until the neovascular disease is stable or
      inactive at which time the interval between visits will increase to 16 weeks.

      Subjects in both groups will be evaluated for efficacy, using best corrected visual acuity
      (BCVA) using the 4-meter ETDRS protocol with normal-luminance, Humphrey Visual Field (HVF),
      National Eye Institute (NEI) Visual Function Questionnaire (VFQ) 25, spectral domain optical
      coherence tomography (SD-OCT), optical coherence tomography angiography (OCT-A), FP, and
      fluorescein angiography (FA), and for ocular and systemic safety (including ophthalmic exams
      and laboratory assessments) through week 112.

      Subjects who develop new or worsening PDR, including anterior segment neovascularization
      (ASNV), or center-involved DME may qualify for rescue treatment.

Aflibercept Injection

Proportion of subjects achieving a DRSS level of 43 or less in the VOYAGE study.

Proportion of subjects achieving a DRSS level of 43 or less from the completion of the PANORAMA study

Proportion of subjects with stable, worsened, or improved DRSS level from baseline to week 48 and baseline to week 112 compared to the DRSS at the baseline of the VOYAGE trial and the DRSS at the last visit of the PANORAMA trial.

Mean and median number of IVT aflibercept injections (with and without IAI given for DME)

Proportion of subjects receiving 0 injections

Percentage of subjects over time who develop a new PDR event

Percentage of subjects over time who develop center-involved (CI) DME

Mean change in central retinal thickness from baseline

Change in total area of retinal capillary non-perfusion from baseline

Changes in visual function outcomes from Humphrey Visual Field from baseline

Changes in visual function outcomes NEI VFQ-25 from baseline

Incidence and severity of ocular and systemic adverse events from baseline

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.

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.

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

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status