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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 112 weeks
Awards & highlights
VOYAGE 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.Check my eligibility
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.See study design
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.
VOYAGE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 112 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~112 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
DRSS Level Achievement in the VOYAGE study
Secondary outcome measures
Center-Involved Diabetic Macular Edema Development
Change in Area of Nonperfusion
Change in Central Retinal Thickness
+9 moreSide effects data
From 2017 Phase 2 trial • 41 Patients • NCT0218155628%
Neutropenia
18%
Venous TE disorders
18%
Hypertension
15%
Mucositis
13%
Abdominal Pain
13%
Diarrhea
8%
Vomiting
5%
Proteinuria
5%
Anemia
5%
Nausea
5%
Leucopenia
5%
Colonic perforation
3%
Large intestinal haemorrhage
3%
Intestinal obstruction
3%
Anal fistula
3%
Decreased appetite
3%
Small intestinal obstruction
3%
Enterocolitis
3%
Large intestinal obstruction
3%
Large intestine perforation
3%
Small intestinal perforation
100%
80%
60%
40%
20%
0%
Study treatment Arm
FOLFIRI and Aflibercept
VOYAGE 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
2017
Completed Phase 4
~150
Find a Location
Who is running the clinical trial?
Greater Houston Retina ResearchLead Sponsor
8 Previous Clinical Trials
461 Total Patients Enrolled
4 Trials studying Diabetic Retinopathy
340 Patients Enrolled for Diabetic Retinopathy
Regeneron PharmaceuticalsIndustry Sponsor
615 Previous Clinical Trials
379,697 Total Patients Enrolled
10 Trials studying Diabetic Retinopathy
1,585 Patients Enrolled for Diabetic Retinopathy
Clinical Trials Resource Group, LLCUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a postmenopausal woman who has not had a period for at least 12 months.I haven't had steroid treatments in my eye for the last 3 months.You have participated in and finished the PANORAMA (VGFTe-OD-1411) clinical trial.I haven't had anti-VEGF treatment for my eye in the last 21 days.I am willing to use effective birth control during the study.I have not had any long-lasting eye treatments, devices, or gene therapy in my study eye.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1
- Group 2: Group 2
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA sanctioned Aflibercept Injection for utilization?
"Aflibercept Injection is a medically approved treatment, so its safety rating was evaluated as 3."
Answered by AI
Are there any available slots open for participants in this experiment?
"Affirmatively, according to clinicaltrials.gov records this medical trial is currently seeking suitable participants. The study was originally made available on June 1st 2021 and was most recently updated January 6th 2022."
Answered by AI
In how many locations is this clinical experiment taking place?
"For this research, patients can enrol at Central Florida Retina Centre in Orlando, FL; Retina Vitreous Associates Medical Group in Beverly Hills, CA and Strategic Clinical Research Group LLC in Willow Park TX. Additionally there are 13 other trial sites available."
Answered by AI
What are the common uses for Aflibercept Injection?
"Wet age-related macular degeneration is often treated with aflibercept Injection, which has also demonstrated efficacy in treating other ocular afflictions such as macular edema, diabetic macular edema and generalised macular degeneration."
Answered by AI
What is the upper limit to participants for this clinical experiment?
"150 volunteers, compliant with the predetermined criteria, are needed to contribute to this clinical trial. Potential participants can take part from select locations such as Central Florida Retina Center in Orlando, Florida and Retina Vitreous Associates Medical Group in Beverly Hills, California."
Answered by AI
Are there other precedents for utilizing Aflibercept Injection in clinical studies?
"Aflibercept Injection was initially looked into in 2014 at the M D Anderson Cancer Center. Since then, 231 trials have been completed, with 45 more currently being conducted; a large portion of these are located in Orlando, Florida."
Answered by AI
Who else is applying?
What state do they live in?
Louisiana
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+
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