AzTrials
AzTrials

Exudative Age-related Macular DegenerationPhase 4FUSIONNCT01500915

FUSION Regimen: Combined Pro re Nata and Fixed Regimen Ranibizumab in Exudative Age-related Macular Degeneration

A Phase 4 study testing Ranibizumab in people with Exudative Age-related Macular Degeneration, run by Institut de la Macula y la Retina at 1 site in Spain.

Completed

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

Official record
Search all trials

Trial summary

The purpose of this study is to investigate the safety and efficacy of a combined fixed-interval and a pro re nata (PRN) regimens of ranibizumab (FUSION regimen) for the treatment of exudative age-related macular degeneration (AMD) in patients with good visual acuity (VA) at baseline. Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
Ranibizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
1 siteSpain
Study dates
Nov 2010to Jul 2012
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

  • subfoveal or juxtafoveal CNV owing to AMD, defined by fluorescein angiography (FA)
  • presence on SD-OCT of subretinal or intraretinal fluid associated or not with macular edema
  • Best corrected visual acuity (BCVA) in the study eye between 20/20 and 20/125, inclusive
  • total area of the lesion (including blood, neovascularization and scar/atrophy) of ≤8 disc areas, of which at least 50% must be active choroidal neovascularization (CNV) (defined as the neovascular component of the lesion as defined by FA
  • all angiographic subtypes [predominantly classic, minimally classic and occult] were eligible)
  • clear ocular media and adequate pupillary dilatation to allow collection of fundus photographs and FA of a sufficient quality to be analyzed
  • intraocular pressure of 21 mmHg or less
  • and no previous treatment for AMD

Who cannot join

  • presence of scarring or atrophy >75% of the total lesion size (patients with subfoveal scar or atrophy were excluded)
  • subretinal haemorrhage >75% of the total lesion size; presence of serous retinal pigment epithelial detachments >5 disc areas
  • presence of intraocular inflammation (≥ trace cell or flare), epiretinal membrane, macular hole or vitreous haemorrhage
  • history of idiopathic or autoimmune-associated uveitis in either eye
  • significant media opacities, including cataract, which might interfere with VA, assessment of toxicity or fundus photography in the study eye
  • presence of other causes of CNV, including pathological myopia (spherical equivalent of -3 diopters or more, or axial length of 25 mm or more, or fundus findings suggestive of pathologic myopia), ocular histoplasmosis syndrome, angioid streaks, choroidal rupture and multifocal choroiditis
Show all 9Show fewer
  • any retinal treatment (aside from antioxidants), including (but not limited to) intravitreal injections, photodynamic therapy with verteporfin, laser photocoagulation or surgery
  • history of rhegmatogenous retinal detachment, pars plana vitrectomy or corneal transplant
  • and previous radiation in the region of the study eye.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Institut de la Macula i de la Retina

    Barcelona, 08022

Other trials in Spain

About this study

Official title: FUSION Regimen: A Disease Activity Guided Treatment Algorithm With Ranibizumab in naïve Subjects With Exudative Age-related Macular Degeneration

The purpose of this study is to investigate the safety and efficacy of a combined fixed-interval and a pro re nata (PRN) regimens of ranibizumab (FUSION regimen) for the treatment of exudative age-related macular degeneration (AMD) in patients with good visual acuity (VA) at baseline. To establish whether similar efficacy to monthly regimens can be achieved with fewer injections, even in patients with good VA.

Read the detailed description

This is a prospective, open-label, consecutive interventional case series in treatment-naïve patients with exudative AMD. A loading phase of 2-3 injections is followed by a fixed-interval regimen of injections combined with a pro re nata regimen for 12 months. Endpoints include VA, presence of fluid at spectral domain optical coherent tomography (SD-OCT), adverse events and number of injections administered.

Being tested
Ranibizumab
Keywords
AMD, ranibizumab, antiVEGF, regimen of injections, anti VEGF regimen, PRN, treat and extend

What participants receive

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

  • RanibizumabDrug

    Also called luncentis

    0,5mg intravitreal ranibizumab

Study groups in NCT01500915
Study groupRoleWhat they receive
ranibizumabExperimentalNot described
Receives: Drug: Ranibizumab

What is being measured

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

  1. mean VA change

    change in ETDRS (early treatment diabetic retinopathy study) letters from baseline to 12 month-visit

    Measured: 12 months

Secondary outcomes (5)

  1. Percentage of patients with gain of ≥5, >10 and ≥15 letters ETDRS

    percentage of patients with gain of ≥5, >10 and ≥15 letters ETDRS at 12 months compared to baseline

    Measured: 12 months

  2. The percentage of patients losing <5, <15 and <30 ETDRS letters

    percentage of patients with lost of <5, <15 and <30 ETDRS letters at 12 months compared to baseline

    Measured: 12 months

  3. The mean VA

    mean VA at 6 and 12 months in ETDRS letters

    Measured: 6 and 12 months

  4. The median VA

    median VA at 6 and 12 months in ETDRS letters

    Measured: 12 months

  5. The mean number of injections

    the mean number of injections administered to patients from baseline to month 12 ( month 12 not included)

    Measured: 12 months

Timeline

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

  1. First posted29 Dec 2011 (estimated)
  2. Study startNov 2010
  3. Primary completionMar 2012
  4. Study completionJul 2012

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
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01500915
Sponsor's protocol ID
FUSION-001-10-2010
Acronym
FUSION
Status last verified
Mar 2015
First submitted
14 Dec 2011
Last updated
24 Mar 2015
Results posted
No
Data monitoring committee
No

Publications

  • Mones J, Biarnes M, Trindade F, Casaroli-Marano R. FUSION regimen: ranibizumab in treatment-naive patients with exudative age-related macular degeneration and relatively good baseline visual acuity. Graefes Arch Clin Exp Ophthalmol. 2012 Dec;250(12):1737-44. doi: 10.1007/s00417-012-2009-5. Epub 2012 Apr 15.

    PubMed 22527314

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ranibizumab in people with Exudative Age-related Macular Degeneration, run by Institut de la Macula y la Retina at 1 site in Spain.

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 8 inclusion and 9 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 24 Mar 2015. 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 Spain. 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?

mean VA change (time frame: 12 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 NCT01500915, 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 24 Mar 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in