FrancophonIA/ELRC3.0 huggingface dataset:
English: If visual and/or anatomic outcomes deteriorate, the treatment interval should be shortened accordingly.
Slovenian: Če se glede na oceno ostrine vida in/ali anatomski izgled rumene pege stanje poslabša, je treba interval med injekcijami ustrezno skrajšati.
English: VEGF levels are elevated in response causing the leakage of fluid into the retina and thereby causing a swelling of the macula, (the portion of the retina responsible for fine vision), which is called macular oedema.
Slovenian: Zaradi iztekanja tekočine v mrežnico se povečajo vrednosti VEGF v krvi, kar povzroči oteklino rumene pege (del mrežnice odgovoren za ostrino vida), kar se imenuje makularni edem.
English: Instructions for use of pre-filled syringe:
Slovenian: Navodilo za uporabo napolnjene injekcijske brizge
English: Patient ages ranged from 27 to 83 years with a mean of 58 years.
Slovenian: Bolniki so bili stari od 27 do 83 let, v povprečju 58 let.
English: A secondary efficacy variable was change in visual acuity at week 24 compared to baseline.
Slovenian: Spremenljivka sekundarne učinkovitosti je bila sprememba v ostrini vida v 24. tednu v primerjavi z izhodiščnimi vrednostmi.
English: Delivers a single dose of 2 mg/0.05 ml.
Slovenian: Za enkratni odmerek 2 mg/0,05 ml.
English: Diabetic macular oedema is a swelling of the retina occurring in patients with diabetes due to leaking of fluid from blood vessels within the macula.
Slovenian: Diabetični makularni edem je oteklina mrežnice, ki se pojavi pri bolnikih s sladkorno boleznijo zaradi iztekanja tekočine iz krvnih žil v rumeni pegi.
English: Eylea is not recommended during breast-feeding.
Slovenian: Uporabe zdravila Eylea se ne priporoča med dojenjem.
English: There is no requirement for monitoring between injections.
Slovenian: Med posameznimi injekcijami spremljanje bolnikov ni potrebno.
English: Patient ages ranged from 49 to 99 years with a mean of 76 years.
Slovenian: Bolniki so bili stari od 49 do 99 let, v povprečju 76 let.
English: Active Control (laser)/Eylea 2mgE)
Slovenian: aktivna kontrola (lasersko zdravljenje) / zdravilo Eylea 2mgE (N = 90)
English: ETDRS: Early Treatment Diabetic Retinopathy Study
Slovenian: BCVA: najboljša korigirana ostrina vida (Best Corrected Visual Acuity) ETDRS: študija zgodnjega zdravljenja diabetične retinopatije (Early Treatment Diabetic Retinopathy Study)
English: In patients treated with Eylea (one injection per month for three consecutive months, followed by one injection every 2 months), central retinal thickness [CRT] decreased soon after treatment initiation, and the mean CNV lesion size was reduced, consistent with the results seen with ranibizumab 0.5 mg every month.
Slovenian: Pri bolnikih, zdravljenih z zdravilom Eylea (ena injekcija na mesec, tri zaporedne mesece, nato pa ena injekcija vsaka dva meseca), se je centralna debelina mrežnice (CRT - Central Retinal Tickness) zmanjšala kmalu po uvedbi zdravljenja in tudi povprečna velikost CNV lezije se je zmanjšala, kar je bilo v skladu z izsledki, vidnimi pri bolnikih, ki so prejemali ranibizumab 0,5 mg vsak mesec.
English: Treatment may then be continued with a treat-and-extend regimen with gradually increased treatment intervals to maintain stable visual and/or anatomic outcomes, however there are insufficient data to conclude on the length of these intervals.
Slovenian: Zdravljenje bo morda treba nadaljevati z režimom »zdravi in podaljšaj«, tj. s postopnim podaljševanjem intervala med injekcijami, da se ohrani stabilen vid in/ali anatomski izgled rumene pege, čeprav ni dovolj podatkov za odločitev glede dolžine intervalov.
English: Week 96 Week 52
Slovenian: 96. teden 52. teden
English: Patients with myopic CNV will be treated with one single injection.
Slovenian: Bolnikom z miopično horoidalno neovaskularizacijo bo zdravilo injicirano enkrat.
English: A After treatment initiation with 5 monthly injections
Slovenian: Po 5 začetnih mesečnih injekcijah
English: Always discuss any suspected side effects with your doctor.
Slovenian: Pri sumu na neželene učinke se vedno posvetujte z zdravnikom.
English: At week 16, patients were randomised 1:1 into two treatment groups: 1) Eylea treat-and-extend with 2-week adjustments and 2) Eylea treat-and-extend with 4-week adjustments.
Slovenian: V 16. tednu so bili bolniki randomizirani (v razmerju 1:1) v dve skupini zdravljenja: 1) skupina zdravljena z zdravilom Eylea, ki so ji interval med injekcijami spreminjali po 2-tedna in 2) skupina zdravljena z zdravilom Eylea, ki so ji interval med injekcijami spreminjali po 4-tedne.
English: Based on pre-specified criteria, patients in the laser group could receive rescue treatment with Eylea 2mg from week 24, administered every 4 weeks for 3 months followed by every 8 weeks.
Slovenian: Glede na vnaprej določene kriterije so bolniki v kontrolni skupini z laserskim zdravljenjem, lahko od 24. tedna prejeli rešilno zdravljenje z zdravilom Eylea v odmerku 2 mg, vsake 4 tedne, tri zaporedne mesece, nato pa so nadaljevali z injekcijami vsakih 8 tednov.
English: In these clinical studies, approximately 89% (1,616/1,817) of the patients randomised to treatment with Eylea were 65 years of age or older, and approximately 63% (1,139/1,817) were 75 years of age or older.
Slovenian: V teh kliničnih študijah je bilo približno 89 % (1.616/1.817) bolnikov, randomiziranih v skupino, ki je prejemala zdravilo Eylea, starih 65 let ali več, približno 63 % (1.139/1.817) jih je bilo starih 75 let ali več.
English: At week 52, patients in the treat-and-extend arm with 2-week adjustments gained a mean of 9.0 letters from baseline as compared to 8.4 letters for those in the 4-week adjustment group [LS mean difference in letters (95% CI): -0.4 (-3.8,3.0), ANCOVA].
Slovenian: V 52. tednu so bolniki v skupini zdravljeni z režimom »zdravi in podaljšaj« pridobili v povprečju 9,0 črk od izhodiščne vrednosti v skupini, ki so ji interval med injekcijami podaljševali po 2 tedna oziroma 8,4 črk v skupini, ki so ji interval med injekcijami podaljševali po 4 tedne [LS razlika v črkah (95 % CI): -0,4 (-3,8; 3,0), ANCOVA].
English: To remove the syringe cap, hold the syringe in one hand while using the other hand to grasp the syringe cap with the thumb and fore finger.
Slovenian: Če želite odstraniti zaščitno zaporko z brizge, brizgo držite z eno roko in s kazalcem in palcem druge roke primite zaščitno zaporko.
English: The magnitude of these changes was similar to that seen in published studies, which corresponded to a 15-letter gain in Best Corrected Visual Acuity (BCVA).
Slovenian: Obseg teh sprememb je bil podoben kot v objavljenih študijah in ustreza pridobitvi 15 črk BCVA (najboljša korigirana ostrina vida).
English: The recommended dose is 2 mg aflibercept (50 microlitres).
Slovenian: Priporočeni odmerek je 2 mg aflibercepta (50 mikrolitrov).
English: • Treatment should be withheld in patients with rhegmatogenous retinal detachment or stage 3 or 4 macular holes.
Slovenian: • Pri bolnikih z regmatogenim odstopom mrežnice ali foramnom makule III. ali IV. stopnje je treba z zdravljenjem prenehati.
English: If a dose of Eylea is missed
Slovenian: Če ste izpustili odmerek zdravila Eylea
English: In the event of either being observed, discard the medicinal product.
Slovenian: Če opazite kar koli od naštetega, je treba zdravilo zavreči.
English: Immediately following the intravitreal injection, patients should be monitored for elevation in intraocular pressure.
Slovenian: Takoj po intravitrealni injekciji je treba preveriti intraokularni tlak.
English: At baseline, the proportion of perfused patients in the Eylea and laser groups was 60% and 68%, respectively.
Slovenian: Na začetku je bil delež perfundiranih bolnikov v skupini, ki je prejemala zdravilo Eylea, in v kontrolni skupini z laserskim zdravljenjem, 60 % oziroma 68 %.
English: After the first 12 months of treatment with Eylea, and based on visual and/or anatomic outcomes, the treatment interval may be extended, such as with a treat-and-extend dosing regimen, where the treatment intervals are gradually increased to maintain stable visual and/or anatomic outcomes; however there are insufficient data to conclude on the length of these intervals.
Slovenian: Po prvih 12 mesecih zdravljenja z zdravilom Eylea in glede na oceno ostrine vida in/ali anatomski izgled rumene pege, se lahko interval med injekcijami podaljša, na primer z režimom odmerjanja »zdravi in podaljšaj«, kjer se intervali med injekcijami postopoma podaljšujejo, da se ohrani stabilna ostrina vida in/ali anatomski izgled rumene pege, čeprav ni dovolj podatkov za odločitev o dolžini teh intervalov.
English: All patients received monthly doses of Eylea 2 mg for 3 months, followed by one injection after a further 2 month interval.
Slovenian: Vsi bolniki so prejemali eno injekcijo zdravila Eylea 2 mg na mesec, tri zaporedne mesece, nato pa še eno injekcijo po dveh mesecih.
English: G) In GALILEO study, both control group and Eylea 2mg patients received Eylea 2 mg on an as-needed basis every 8 weeks starting from week 52 to week 68; patients had mandatory visits every 8 weeks.
Slovenian: V študiji GALILEO so bolniki v kontrolni skupini in bolniki zdravljeni z zdravilom Eylea 2 mg, od 52. do 68. tedna, prejemali zdravilo Eylea 2 mg glede na potrebe vsakih 8 tednov; bolniki so imeli obvezne preglede vsakih 8 tednov.
English: Pregnancy and breast-feeding - Women of childbearing potential have to use effective contraception during treatment and for at least three further months after the last injection of Eylea.
Slovenian: Nosečnost in dojenje - Ženske v rodni dobi morajo med zdravljenjem in še vsaj tri mesece po zadnji injekciji zdravila
English: • Key signs and symptoms of intravitreal injection related adverse events including endophthalmitis, increased intraocular pressure, retinal pigment epithelial tear and cataract
Slovenian: • ključne znake in simptome neželenih učinkov, povezanih z intravitrealnim injiciranjem, vključno z endoftalmitisom, povišanim intraokularnim tlakom, zatrganjem pigmentnega epitelija mrežnice in katarakto
English: It is estimated that after intravitreal administration of 2 mg to patients, the mean maximum plasma concentration of free aflibercept is more than 100-fold lower than the concentration of aflibercept required to half-maximally bind systemic VEGF (2.91 microgram/ml) in a study of healthy volunteers.
Slovenian: V študiji z zdravimi prostovoljci so ocenili, da je po intravitrealnem odmerku 2 mg aflibercepta povprečna največja koncentracija prostega aflibercepta v plazmi več kot 100-krat nižja kot koncentracija aflibercepta, potrebna za vezavo polovice sistemskega VEGF (2,91 mikrogramov/ml).
English: One pre-filled syringe contains 90 microlitres, equivalent to 3.6 mg aflibercept.
Slovenian: Ena napolnjena injekcijska brizga vsebuje 90 mikrolitrov raztopine, kar ustreza 3,6 mg aflibercepta.
English: The primary efficacy endpoint was mean change in BCVA from baseline to week 52.
Slovenian: Primarni cilj učinkovitosti je bila povprečna sprememba BCVA od izhodiščne vrednosti do 52. tedna.
English: Efficacy Outcome
Slovenian: Izid učinkovitosti
English: Diabetic macular oedema (DME)
Slovenian: Diabetični makularni edem (DME)
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Single dose = 2 mg/50 microlitres Extractable content = 4 mg/100microlitres
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT enkratni odmerek = 2 mg/50 mikrolitrov vsebnost viale = 4 mg/100 mikrolitrov
English: SPECIAL STORAGE CONDITIONS Store in refrigerator (2°C to 8°C).
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte v hladilniku (2 ºC - 8 ºC).
English: The vial is for single use in one eye only.
Slovenian: Ena viala je samo za enkratno uporabo v enem očesu.
English: Final study report submission:
Slovenian: predložitev končnega poročila o študiji: november
English: At the 0.1 mg/kg dose, the systemic exposures based on Cmax and cumulative AUC for free aflibercept were approximately 17- and 10-fold higher, respectively, when compared to corresponding values observed in humans after an intravitreal dose of 2 mg.
Slovenian: Pri odmerku 0,1 mg/kg je bila sistemska izpostavljenost prostemu afliberceptu glede na Cmax približno 17-krat oziroma glede na kumulativni AUC približno 10-krat večja v primerjavi z ustreznimi vrednostmi, ki so jih opazili pri ljudeh po intravitrealnem odmerku 2 mg.
English: The macula is the portion of retina responsible for fine vision.
Slovenian: Rumena pega je del mrežnice, odgovorna za ostrino vida.
English: In a pharmacokinetic sub-study in 6 neovascular wet AMD patients with frequent sampling, maximum plasma concentrations of free aflibercept (systemic Cmax) were low, with a mean of approximately 0.02 microgram/ml (range 0 to 0.054) within 1 to 3 days after a 2 mg intravitreal injection, and were undetectable two weeks following dosage in almost all patients.
Slovenian: V farmakokinetični podštudiji pri 6 bolnikih z neovaskularno vlažno AMD, ki so jim pogosto jemali vzorce krvi, so bile največje plazemske koncentracije prostega aflibercepta (sistemski Cmax) majhne, v povprečju približno 0,02 mikrograma/ml (v razponu od 0 do 0,054) v 1 do 3 dneh po intravitrealnem odmerku 2 mg.
English: Your doctor will then decide whether the treatment interval between injections may be kept at every two months or be gradually extended in 2- or 4-weekly intervals if your condition has been stable.
Slovenian: Če je vaše stanje stabilno, se bo zdravnik odločil, ali lahko interval med injekcijami ostane vsaka dva meseca, ali pa se postopoma podaljšuje po 2- ali 4-tedne.
English: This provides a usable amount to deliver a single dose of 50 microlitres containing 2 mg aflibercept.
Slovenian: To zadostuje za aplikacijo enega odmerka po 50 mikrolitrov, ki vsebuje 2 mg aflibercepta.
English: Efficacy results in all evaluable subgroups (e.g. age, gender, race, baseline visual acuity, lesion type, lesion size) in each study and in the combined analysis were consistent with the results in the overall populations.
Slovenian: Izsledki glede učinkovitosti v vseh ocenjenih podskupinah (npr. glede na starost, spol, raso, ostrino vida ob izhodišču, vrsto lezije, velikost lezije) v vsaki študiji in v analizi združenih podatkov so bili v skladu z izsledki za celotno populacijo.
English: There are limited data on safety in the treatment of patients with CRVO, BRVO, DME or myopic CNV with a history of stroke or transient ischaemic attacks or myocardial infarction within the last 6 months.
Slovenian: Podatki o varnosti zdravljenja bolnikov s CRVO, BRVO, DME ali miopično CNV z anamnezo možganske kapi, prehodnih ishemičnih napadov ali miokardnega infarkta v zadnjih 6 mesecih, so omejeni.
English: At the last visit prior to week 96, 64.9% and 61.2% of patients in the 2week and 4-week adjustment groups, respectively had their next injection scheduled at an interval of 12 weeks or beyond.
Slovenian: Na zadnjem obisku pred 96. tednom je 64,9 % bolnikov v skupini, ki so ji interval med injekcijami podaljševali po 2 tedna, in 61,2 % bolnikov, ki so ji interval med injekcijami podaljševali po 4 tedne, prejelo naslednjo injekcijo po 12 tednih ali kasneje.
English: • In the event of a retinal break the dose should be withheld and treatment should not be resumed until the break is adequately repaired.
Slovenian: • Če pride do raztrganja mrežnice, je treba z zdravljenjem prenehati.
English: • neovascular (wet) age-related macular degeneration (AMD) (see section 5.1),
Slovenian: • neovaskularne (vlažne) starostne degeneracije makule (AMD - Age-related Macular Degeneration) (glejte poglavje 5.1),
English: Eliminate all bubbles and expel excess medicinal product by slowly depressing the plunger so that the plunger tip aligns with the line that marks 0.05 ml on the syringe.
Slovenian: Odstranite vse mehurčke in iztisnite odvečno zdravilo s počasnim pritiskanjem na bat, dokler se konica bata ne poravna s črto na brizgi, ki označuje 0,05 ml.
English: Do not drive or use machines as long as these last.
Slovenian: Dokler imate motnje vida, ne vozite in ne upravljajte strojev.
English: Patient ages ranged from 23 to 87 years with a mean of 63 years.
Slovenian: Bolniki so bili stari od 23 do 87 let, v povprečju 63 let.
English: The proportion of patients who did not lose ≥15 letters in the two treatment arms was similar (96.7% in the 2-week and 95.9% in the 4-week adjustment groups).
Slovenian: Delež bolnikov, ki niso izgubili ≥15 črk je bil podoben v obeh skupinah (96,7 % v skupini, ki so ji interval med injekcijami podaljševali po 2 tedna oziroma 95,9 % v skupini, ki so ji interval med injekcijami podaljševali po 4 tedne).
English: Eylea treatment is initiated with one injection per month for three consecutive doses.
Slovenian: Zdravljenje z zdravilom Eylea se začne z eno injekcijo na mesec, tri zaporedne mesece.
English: 1 pre-filled syringe (3.6 mg/90 microlitres) Single dose: 2 mg/0.05 ml Excess volume to be expelled.
Slovenian: 1 napolnjena injekcijska brizga (3,6 mg/90 mikrolitrov) Enkratni odmerek: 2 mg/0,05 ml
English: One vial contains 4 mg aflibercept in 100 microlitres (40 mg/ml) in iso-osmotic solution.
Slovenian: Ena viala vsebuje 4 mg aflibercepta v 100 mikrolitrih (40 mg/ml) izoosmotske raztopine.
English: Difference in LS meanA,C,D,E)
Slovenian: Razlika v povprečni vrednosti LSA,C,D,E
English: In both studies, the primary efficacy endpoint was the proportion of patients who gained at least 15 letters in BCVA at week 24 compared to baseline.
Slovenian: V obeh študijah je bil primarni cilj učinkovitosti delež bolnikov, ki so pridobili vsaj 15 črk BCVA v 24. tednu v primerjavi z izhodiščnimi vrednostmi.
English: In combined data analysis of VIEW1 and VIEW2 Eylea demonstrated clinically meaningful changes from baseline in pre-specified secondary efficacy endpoint National Eye Institute Visual Function Questionnaire (NEI VFQ-25) without clinically meaningful differences to ranibizumab.
Slovenian: V analizi združenih podatkov iz študij VIEW1 in VIEW2 je pri zdravljenju z zdravilom Eylea prišlo do klinično značilnih sprememb vnaprej določenega sekundarnega cilja učinkovitosti po vprašalniku National Eye Institute Visual Function Questionnaire (NEI VFQ-25) glede na izhodiščne vrednosti, brez klinično pomembnih razlik v primerjavi z ranibizumabom.
English: Patient ages ranged from 22 to 89 years with a mean of 64 years.
Slovenian: Bolniki so bili stari od 22 do 89 let, v povprečju 64 let.
English: In the DME studies, approximately 47% (268/576) of the patients randomised to treatment with Eylea were 65 years of age or older, and approximately 9% (52/576) were 75 years of age or older.
Slovenian: V študijah DME je bilo približno 47 % (268/576) bolnikov, randomiziranih v skupino, ki je prejemala zdravilo Eylea, starih 65 ali več, približno 9 % (52/576) jih je bilo starih 75 let ali več.
English: Proportion of patients with ≥15 letters gain from Baseline (%) Weighted Difference A,B) (95% CI) p-value p=0.0003
Slovenian: Delež bolnikov, ki so pridobili > 15 črk glede na izhodiščne vrednosti Prilagojena razlikaA,B,E (95 % IZ) vrednost p p < 0,0001
English: Table 3: Efficacy outcomes at week 24, week 52 and week 76/100 (Full Analysis Set with LOCFC)) in COPERNICUS and GALILEO studies Efficacy Outcomes
Slovenian: Preglednica 3: Izidi učinkovitosti v 24. tednu, 52. tednu in 76. tednu/100 (celotna analiza z LOCFC) v študijah COPERNICUS in GALILEO Izid učinkovitosti
English: • visual impairment due to myopic choroidal neovascularisation (myopic CNV) (see section 5.1).
Slovenian: • okvare vida zaradi miopične horoidalne neovaskularizacije (miopične CNV - myopic Choroidal Neovascularisation) (glejte poglavje 5.1).
English: Injecting the entire volume of the vial could result in overdose.
Slovenian: Injiciranje celotnega volumna viale lahko povzroči preveliko odmerjanje.
English: Sham (N = 31)
Slovenian: placebo (N = 31)
English: The reduction in CRT was generally maintained in both treatment arms in the second year of the ALTAIR study.
Slovenian: V drugem letu študije ALTAIR se je zmanjšanje CRT na splošno ohranilo v obeh skupinah zdravljenja.
English: Injecting the entire volume of the prefilled syringe could result in overdose.
Slovenian: Injiciranje celotnega volumna napolnjene injekcijske brizge lahko povzroči preveliko odmerjanje.
English: One vial contains 100 microlitres, equivalent to 4 mg aflibercept.
Slovenian: Ena viala vsebuje 100 mikrolitrov raztopine, kar ustreza 4 mg aflibercepta.
English: Eliminate all bubbles and expel excess medicinal product by slowly depressing the plunger to align the cylindrical base of the dome plunger with the black dosing line on the syringe (equivalent to 50 microlitres).
Slovenian: Odstranite vse mehurčke in iztisnite odvečno zdravilo s počasnim pritiskanjem na bat, dokler se ravni rob cilindrične glave bata ne poravna s črno črto za odmerjanje na brizgi (ustreza 50 mikrolitrom).
English: In the study, patients were randomly assigned in a 1:1 ratio to either 2 mg Eylea administered every 8 weeks following 6 initial monthly injections or laser photocoagulation administered at baseline (laser control group).
Slovenian: V študiji so bolnike naključno razporedili v razmerju 1:1 v skupino, ki je po 6 začetnih zaporednih mesečnih injekcij ali začetnem zdravljenju z lasersko fotokoagulacijo (kontrolna skupina z laserskim zdravljenjem), vsakih 8 tednov prejemala 2 mg zdravila Eylea.
English: STATEMENT OF ACTIVE SUBSTANCE Aflibercept
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN aflibercept
English: Intravitreal injection-related reactions
Slovenian: Reakcije povezane z intravitrealnimi injekcijami
English: Detailed results from the combined analysis of both studies are shown in Table 2 and Figure 1 below.
Slovenian: Podrobnejši izsledki analiz združenih podatkov iz obeh študij so prikazani v preglednici 2 in sliki 1.
English: Efficacy Outcomes
Slovenian: Izidi učinkovitosti
English: 100 microlitres of solution in a vial (type I glass) with a stopper (elastomeric rubber), and an 18 G filter needle.
Slovenian: 100 mikrolitrov raztopine v viali (steklo tipa I) z zamaškom (elastomerna guma) in filtrirno iglo 18 G. Velikost pakiranja je 1 viala.
English: At week 100 the decrease was maintained with -195.8 and -191.1 microns for the 2Q8 Eylea groups and -85.7 and -83.9 microns for the control groups, in the VIVIDDME and VISTADME studies, respectively.
Slovenian: V študijah VIVIDDME in VISTADME se je zmanjšanje v 100. tednu ohranilo pri -195,8 mikronov oziroma -191,1 mikronov v skupinah, ki so prejemale zdravilo Eylea 2Q8, ter -85,7 mikronov oziroma -83,9 mikronov v kontrolnih skupinah.
English: C) LS mean: Least square means derived from ANCOVA model D) CI: Confidence Interval
Slovenian: LS: povprečje najmanjših kvadratov, izpeljano z analizo kovariance ANCOVA (Least square means derived from ANCOVA)
English: Holding the syringe with the needle pointing up, check the syringe for bubbles.
Slovenian: Brizgo držite z iglo navpično navzgor, in preverite, če so v brizgi mehurčki.
English: In both studies, the primary efficacy endpoint was the proportion of patients in the Per Protocol Set who maintained vision, i.e. losing fewer than 15 letters of visual acuity at week 52 from baseline.
Slovenian: V obeh študijah je bil primarni cilj učinkovitosti delež bolnikov, ki so ohranili vid, tj. izguba manj kot 15 črk ostrine vida v 52. tednu v primerjavi z izhodiščnimi vrednostmi.
English: • There is limited experience with treatment of patients with ischaemic CRVO and BRVO.
Slovenian: • Na voljo so omejene izkušnje z zdravljenjem bolnikov z ishemično zaporo centralne mrežnične vene ali veje mrežnične vene.
English: Treatment effects in evaluable subgroups (e.g., age, gender, race, baseline HbA1c, baseline visual acuity, prior anti-VEGF therapy) in each study and in the combined analysis were generally consistent with the results in the overall populations.
Slovenian: Učinkovitost zdravljenja v vseh ocenjenih podskupinah (npr. glede na starost, spol, raso, izhodiščni HbA1c, ostrino vida ob izhodišču, predhodno zdravljenje z zaviralci VEGF) v vsaki študiji in v analizi združenih podatkov je bila običajno v skladu z izsledki za celotno populacijo.