VITAL - Individualising Therapy for Neovascular AMD With Aflibercept

NCT02441816 | Completed Phase 4 DMC

• 1 other identifier: 2014-002381-73
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Age Related Macular Degeneration

Keywords

wet AMD; neovascular AMD

Outcome Measures

Primary Outcomes (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.

  24 months

Study Arms (1)

Eylea Treatment

OTHER

The 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.

Drug: Aflibercept; Other: Extend Treatment

Interventions

Aflibercept DRUG

Also known as: Eylea

Eylea Treatment

Extend Treatment OTHER

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).

Eylea Treatment

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• Subjects who meet the following criteria will be excluded from study participation:
• 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.
• 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

Sponsors & Collaborators

• Moorfields Eye Hospital NHS Foundation Trust: lead

Study Sites (1)

Moorfields Eye Hospital NHS Foundation Trust

London, EC1V 2PD, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 32557168 DERIVED

MeSH Terms

Conditions

Macular Degeneration

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Praveen Patel, MD

  Moorfields Eye Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2014
• First Posted: May 12, 2015
• Study Start: November 1, 2014
• Primary Completion: January 26, 2018
• Study Completion: January 26, 2018
• Last Updated: May 23, 2018

Record last verified: 2018-05

Locations

GB (1)