The FUSION Regimen for Exudative AMD

jmones@institutmacularetina.com
Therationaleforthe FUSION Regimen
Jordi Monés
Institutde la Màcula i de la Retina
Centro Médico Teknon, Barcelona

Monthlyregimen: Marina Anchor

Quarterlyregimen: PIER

Monthy vs quarterly: EXCITE

Ondemand (PRN): SUSTAIN

Mean VA ARMS of mainTrials

PRN seemstoworkfor CNV 2ry tomyopia
MonésJ, Amselem L , Serrano A , García M , Hijano M. Intravitrealranibizumab for choroidalneovascularization secondary to pathologic myopia: 12-month results. Eye. 2009 Jun;23(6):1275-80

PRN inferior tomonthly in AMD
BiarnésM, Monés J, Villalbí JR, Arias L. [Epub ahead of print] As-needed treatment with ranibizumab 0.5 mg in patients with neovascular age-related macular degeneration.Eur J Ophthalmol. 2010 Sep 29.

“THE” slide: Dynamics of lost and recovery of VA afterrelapse

…so, which is likely to be the key??
MONTLY treatmentANTICIPATESdiseaseactivity, treatment has theinitiative
PRN treatment, bydefinition, LAG BEHIND diseaseactivity, thedisease has theinitiative

Then..which would be the IDEAL treatment?
TryingtoANTICIPATEtheactivityprogressionBUT WITHOUT monthlyinjections
FUSION Regimenproposal:
PRNRegimen + FIXEDinjectionsaftercertain time of inactivity

FUSION Regimen
(Ophthalmolgica, Epub ahead):
Loadingphase
( 2 or 3 )
+
PRN treatment
( follow-up /4-6w)
+
Fixedmaintenanceinjections
Aftercertain time of inactivity

Regimen FUSION ( J Monés, Ophthalmolgica, Epub ahead):

Retrospectivestudy of17 “NAIVE” eyes of 17 patients(14/17 women, 82%)
Median age 77 years (66 a 85), 17/17 caucasians; 7/17 OD (41.2%)
Median basal BCVA 67letters (Snellen20/50++), rangefrom 45 (20/125) to 85 (20/20)
“Subgroups” BCVA basal <20/40: 58 (20/63--, median),
BCVA basal>=20/40: 81.5 (20/25++, median)

Median time of follow-up: 6 months(rangefrom 4 to 12m)
Final median BCVA 73 (20/32--), rangefrom 49 (20/100-) to 85 (20/20)
Mean change of +6 letters(p<0.05)

6/17 (35.3%) neededthe 3 loading IVI
in themaintenancephase, retreatmentwasperformed in 33/65 (50.8%) as maintenance(no exudation). In theresttherewassomeextent of exudation
Adverse events: 1 RPE tear (1/17, 5.9%)

% of stabilization: Losslessthan 1 line: 13/17 (76.5%)

% of stabilization: Losslessthan 1 line by “subgroups” (p>0.05):
BCVA basal <20/40 (6/8, 75%)
BCVA basal >=20/40 (7/9, 77.8%)

% of patientsavoidingmoderate visual loss ( 15 letters): 17/17 (100%)
% of significantimprovement of VA (>=15 letters): 2/17 (11.8%)
% of significantimprovement (>=15 letters) in basal BCVA <20/40: 2/11 (18.2%)

baseline
1m
7m
5m
2m
20/40
20/50
20/50
20/80

10m
13m
16m
20m
24m
20/40
20/40
20/40
20/50

thisregimentreatmentbetteranticipatestherelapse of activity, and mayavoidtheloss of thevisiongainedin theloadingphase
Ifconfirmed in a largerscale trial, FUSIONregimenmaybeanalternative t tothemonthlyinjectionregimenbutmaintainingitsadvantages, differentlyfromthe PRN regimens
treating (apparently) inactive eyesdemandsmuch more understandingfrompatients, and more difficulttohandlepotentialcomplications. However, byfaritiswithinthenumber of injections of thebestcurrentstandard of care, monthlyinjections

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The FUSION Regimen for Exudative AMD

by Institut de la Màcula i de la Retina on Feb 06, 2011

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The FUSION Regimen for Exudative AMD — Presentation Transcript