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Age Related Macular DegenerationPhase 4VITALNCT02441816

VITAL - Individualising Therapy for Neovascular AMD With Aflibercept

A Phase 4 study testing Aflibercept and Extend Treatment in people with Age Related Macular Degeneration, run by Moorfields Eye Hospital NHS Foundation Trust at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to assess a new treatment pattern for aflibercept. The aim is to achieve and maintain the best benefit of visual function and avoid unnecessary hospital visits. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Age Related Macular Degeneration
What is being tested?
Aflibercept and Extend Treatment
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited Kingdom
Study dates
Nov 2014to 26 Jan 2018
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent form
  • Age ≥ 50 years of either gender
  • Women must be postmenopausal for at least 12 months prior to trial entry, or surgically sterile. If of child bearing potential, a serum pregnancy test with a negative result must be obtained within 14 days prior to the first treatment.
  • Women of child bearing potential must be practicing effective contraception implemented during the trial and for at least 60 days following the last dose of study medication.
  • No condition that precludes follow-up for 2 years.
  • No contraindication to intravitreous injection of aflibercept.
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  • Study eyes must meet the following criteria for entry into the trial and must have vision loss accounted for by wet AMD:
  • Newly diagnosed, angiographically documented, previously untreated, active CNV lesion (i.e., leakage on fluorescein angiography AND subretinal, intraretinal, or sub-RPE fluid on OCT) secondary to age-related macular degeneration.
  • Best corrected visual acuity score in the study eye of between 80 and 23 letters inclusive, using ETDRS testing, (between 6/7.5 and 6/96 Snellen equivalent), inclusive.
  • The CNV or sequela of the CNV (i.e., pigment epithelium detachment, subretinal haemorrhage, blocked fluorescence, macular edema, or subretinal or intraretinal fluid) must involve the centre of the fovea.
  • The total area of fibrosis must comprise less than 50% of the total lesion.
  • > 1 drusen (>63 microns) in either eye OR late AMD in fellow eye
  • No previous treatment for CNV in the study eye
  • Clear ocular media and adequate pupillary dilation to permit good quality fundus imaging.

Who cannot join

  • Subjects who meet the following criteria will be excluded from study participation:
  • 6.2.1 Prior/Concomitant Treatment
  • Any previous treatments for wet AMD (including verteporfin PDT, Macugen®, Lucentis®, intravitreous Avastin®, thermal laser, external beam radiation or surgery for AMD) in the study eye
  • Current or planned use of systemic medications known to be toxic to the lens, retina or optic nerve, including deferoxamine, chloroquine/ hydroxychloroquine (Plaquenil®), phenothiazines and ethambutol.
  • Previous participation in any studies of investigational drugs likely to have ocular effects within 30 days preceding the initial study treatment
  • Concurrent or previous use of systemic anti-VEGF agents.
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  • Any intraocular procedure (including Yttrium-Aluminium-Garnet capsulotomy) within 2 months prior to Screening or anticipated within the next 6 months following Screening 6.2.2 Lesion Characteristics
  • Permanent structural damage (fibrosis or atrophy) involving the centre of the fovea in the study eye
  • CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia
  • Retinal pigment epithelial tear involving the fovea in the study eye 6.2.3 Concurrent Ocular Conditions
  • Any concurrent intraocular condition in either eye (e.g., cataract or diabetic retinopathy) that, in the opinion of the investigator, could either require medical or surgical intervention during the 2 year follow-up period to prevent or treat visual loss that might result from that condition, or, if allowed to progress untreated, could likely contribute to loss of at least 2 Snellen equivalent lines of best corrected visual acuity over the 2 year follow-up period.
  • Active or recent (within 4 weeks) intraocular inflammation (grade trace or above) in either eye
  • Neovascularisation of the iris, neovascular glaucoma or vitreous haemorrhage in either eye at the screening visit
  • History of rhegmatogenous retinal detachment, epiretinal membrane, vitreomacular traction or macular hole in the study eye if in the investigators opinion, thought to limit potential for vision improvement after treatment for wet AMD
  • History of vitrectomy in study eye
  • Active infectious conjunctivitis, blepharitis, keratitis, scleritis, or endophthalmitis in either eye at the time of screening
  • Spherical equivalent of the refractive error in the study eye demonstrating more than 8 diopters of myopia
  • For subjects who have undergone prior refractive or cataract surgery in the study eye, the preoperative refractive error in the study eye cannot exceed 8 diopters of myopia.
  • Intraocular surgery (including cataract surgery) in the study eye within 2 months preceding the first study treatment.
  • Uncontrolled glaucoma in either eye at the time of screening (defined as intraocular pressure >25 mmHg despite treatment with anti-glaucoma medication)
  • Inability to be photographed or to document CNV (eg due to allergy to fluorescein dye, lack of venous access or cataract obscuring the CNV).
  • Inability to obtain OCT images of reasonable quality to allow analysis of lesion or macular fluid
  • Patients with other ocular diseases or conditions that can compromise the visual acuity of the study eye such as amblyopia, anterior ischemic optic neuropathy, previous complicated cataract surgery, aphakia, vitreomacular traction or diabetic macular oedema 6.2.4 Concurrent Systemic Conditions
  • Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 6 weeks after treatment discontinuation. Females of childbearing potential must have a negative pregnancy test within 14 days prior to being registered for trial treatment NOTE: Subjects are considered not of child bearing potential if they are surgically sterile (i.e. they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal.
  • Pregnancy or breastfeeding
  • History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk for treatment complications
  • Current treatment for active systemic infection
  • Evidence of significant uncontrolled concomitant diseases such as cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders
  • History of recurrent significant infections or bacterial infections
  • Inability to comply with study or follow-up procedures
  • Stroke or myocardial infarction less than 3 months from Screening date
  • Known hypersensitivity to aflibercept

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Moorfields Eye Hospital NHS Foundation Trust

    London, EC1V 2PD

Other trials in United Kingdom

About this study

The purpose of this study is to assess a new treatment pattern for aflibercept. The aim is to achieve and maintain the best benefit of visual function and avoid unnecessary hospital visits.

The hypothesis to be tested is whether intravitreous aflibercept given in an 8 week cycle of treatment in year 1 and a capped treat and extend treatment paradigm in year 2 can lead to improved vision and reading speed in eyes with active wet AMD over 2 years while reducing hospital visits.

Being tested
Aflibercept, Extend Treatment
Keywords
wet AMD, neovascular AMD
Medical subject headings
Macular Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AfliberceptDrug

    Also called Eylea

  • Extend TreatmentOther

    In year 2 of the study a treat and extend protocol will be applied, if a patient has signs of disease activity (eg macular fluid on SDOCT) they will be brought back at 8 weeks after the visit and given an intravitreous injection. They will then be reviewed 8 weeks post treatment for a further treatment with follow-up and treatment interval extended to 10 weeks if the disease is quiescent (if no macular fluid at the subsequent visit the patient could be extended to 12 weeks interval with treatment).

Study groups in NCT02441816
Study groupRoleWhat they receive
Eylea TreatmentOtherThe intravitreal dose of Eylea will be 2mg (in 0.05ml) per injection. The medication will be supplied in single use vials. Given monthly for 3 months and then every 8 weeks in the first year of treatment before applying a treat and extend paradigm to patient visits in year 2. This is an open-label study.
Receives: Drug: Aflibercept; Other: Extend Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary outcome - mean change in visual acuity (Early Treatment of Diabetic Retinopathy Study letter score)

    The primary outcome is the mean change in visual acuity (Early Treatment of Diabetic Retinopathy Study letter score) at 24 months from baseline.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2015 (estimated)
  2. Study startNov 2014
  3. Primary completion26 Jan 2018
  4. Study completion26 Jan 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02441816
Sponsor's protocol ID
2014-002381-73
Other IDs
2014
Acronym
VITAL
Status last verified
May 2018
First submitted
20 Oct 2014
Last updated
23 May 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Patel PJ, Jayaram H, Eleftheriadou M, Vazquez-Alfageme C, Islam N, Rubin GS, Pal B, Addison PK, Hamilton R, Degli Esposti S. Individualizing Therapy for Neovascular Age-Related Macular Degeneration with Aflibercept (VITAL): A Two-Year Prospective, Interventional Single-Centre Trial. Ophthalmol Ther. 2020 Sep;9(3):563-576. doi: 10.1007/s40123-020-00267-5. Epub 2020 Jun 18.

    PubMed 32557168

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Aflibercept and Extend Treatment in people with Age Related Macular Degeneration, run by Moorfields Eye Hospital NHS Foundation Trust at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary outcome - mean change in visual acuity (Early Treatment of Diabetic Retinopathy Study letter score) (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02441816, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2018.

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