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Monoclonal Antibodies

Aflibercept for Diabetic Retinopathy (VOYAGE Trial)

Phase 4

Waitlist Available

Research Sponsored by Greater Houston Retina Research

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Any intra- or periocular corticosteroid treatment in the study eye within 3 months of baseline

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 112 weeks

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial will assess the severity of diabetic retinopathy, over 112 weeks, in subjects who completed a previous 2-year trial and were treated in a clinical setting.

Who is the study for?

This trial is for people who finished the PANORAMA study, treating diabetic retinopathy with Aflibercept. Participants must follow clinic visits and procedures, and give consent. Excluded are those recently treated with similar drugs or eye steroids, pregnant or breastfeeding women, and those not using contraception.

What is being tested?

The VOYAGE trial tests the long-term effects of Aflibercept injections on diabetic retinopathy severity over 112 weeks in patients from a previous trial. It checks how well their retina disease is managed when given as needed in a clinical setting.

What are the potential side effects?

While specific side effects for this trial aren't listed here, generally Aflibercept can cause eye redness or irritation, blurred vision, cataracts, increased intraocular pressure among others. Each patient's experience may vary.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't had steroid treatments in my eye for the last 3 months.

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I am willing to use effective birth control during the study.

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I am a postmenopausal woman who has not had a period for at least 12 months.

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I have not had any long-lasting eye treatments, devices, or gene therapy in my study eye.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 112 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~112 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 112 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

DRSS Level Achievement in the VOYAGE study

Secondary study objectives

Center-Involved Diabetic Macular Edema Development

Change in Area of Nonperfusion

Change in Central Retinal Thickness

+9 more

Side effects data

From 2017 Phase 2 trial • 41 Patients • NCT02181556

28%

Neutropenia

18%

Hypertension

18%

Venous TE disorders

15%

Mucositis

13%

Diarrhea

13%

Abdominal Pain

Vomiting

Colonic perforation

Anemia

Proteinuria

Leucopenia

Nausea

Enterocolitis

Large intestine perforation

Large intestinal haemorrhage

Small intestinal obstruction

Small intestinal perforation

Anal fistula

Decreased appetite

Large intestinal obstruction

Intestinal obstruction

100%

80%

60%

40%

20%

Study treatment Arm

FOLFIRI and Aflibercept

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Group 2Experimental Treatment1 Intervention

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.

Group II: Group 1Experimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Aflibercept Injection

2019

Completed Phase 4

~180

0 / 4Eligibility criteria met