FrancophonIA/ELRC3.0 huggingface dataset:
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).
Croatian: Opseg tih promjena bio je sličan onome u objavljenim ispitivanjima, a odgovarao je povećanju za 15 slova kod najbolje korigirane oštrine vida (BCVA).
English: A total of 181 patients were treated and evaluable for efficacy (91 with Eylea).
Croatian: Liječen je ukupno 181 bolesnik u kojeg je procijenjena djelotvornost (91 bolesnik liječen lijekom Eylea).
English: • Do not use this medicine after the expiry date which is stated on the carton and label after EXP.
Croatian: • Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici iza oznake „Rok valjanosti“ ili „EXP“.
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.
Croatian: Procjenjuje se da je nakon intravitrealne primjene 2 mg bolesnicima, srednja vrijednost najveće koncentracije slobodnog aflibercepta u plazmi više nego 100 puta niža od koncentracije aflibercepta potrebne da upola maksimalno veže sistemski VEGF (2,91 mikrograma/ml) u ispitivanju u zdravih dobrovoljaca.
English: The interval between two doses should not be shorter than one month.
Croatian: Interval između dvije doze ne smije biti kraći od jednog mjeseca.
English: Following intravitreal injection patients should be instructed to report any symptoms suggestive of endophthalmitis (e.g. eye pain, redness of the eye, photophobia, blurring of vision) without delay.
Croatian: Nakon intravitrealne injekcije bolesnike treba uputiti da odmah prijave sve simptome koji ukazuju na endoftalmitis (npr. bol u oku, crvenilo oka, fotofobija, zamagljen vid).
English: Arterial thromboembolic events (ATEs) are adverse events potentially related to systemic VEGF inhibition.
Croatian: Arterijski tromboembolijski događaji (ATE) su štetni događaji koji mogu biti povezani sa sistemskom VEGF inhibicijom.
English: After opening the blister, proceed under aseptic conditions.
Croatian: Nakon otvaranja blistera, postupak treba nastaviti u aseptičkim uvjetima.
English: DifferenceC) (95% CI)D)
Croatian: RazlikaC) (95% CI)D)
English: • Patient information packs
Croatian: • Paket informacija za bolesnike
English: • How to prepare for Eylea treatment
Croatian: • Kako se pripremiti za liječenje lijekom Eylea
English: In the clinical trials, there was an increased incidence of bleeding from small blood vessels in the outer layers of the eye (conjunctival haemorrhage) in patients with wet AMD receiving blood thinners.
Croatian: U kliničkim je ispitivanjima incidencija krvarenja iz malih krvnih žila u vanjskim slojevima oka (krvarenje u spojnicu) bila povišena u bolesnika s vlažnim AMD-om koji su uzimali lijekove za razrjeđivanje krvi.
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.
Croatian: Trudnoća i dojenje - Žene reproduktivne dobi moraju koristiti učinkovitu kontracepciju tijekom liječenja i najmanje tri mjeseca nakon zadnje injekcije lijeka Eylea.
English: Aflibercept is produced in Chinese hamster ovary (CHO) K1 cells by recombinant DNA technology.
Croatian: Aflibercept se stvara u K1 stanicama jajnika kineskog hrčka (CHO) tehnologijom rekombinantne DNK.
English: To deter the introduction of air, ensure the bevel of the filter needle is submerged into the liquid.
Croatian: Kako biste spriječili uvlačenje zraka, pazite da kosi vrh filtar-igle bude uronjen u tekućinu.
English: Diabetic macular oedema is a consequence of diabetic retinopathy and is characterised by increased vasopermeability and damage to the retinal capillaries which may result in loss of visual acuity.
Croatian: Dijabetički makularni edem posljedica je dijabetičke retinopatije i obilježen je povećanom vaskularnom permeabilnošću i oštećenjem kapilara mrežnice, što može dovesti do gubitka oštrine vida.
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.
Croatian: Na temelju prethodno definiranih kriterija, bolesnici u skupini s laserom mogli su primiti spasonosno liječenje lijekom Eylea 2 mg od 24. tjedna, primijenjeno svaka 4 tjedna tijekom 3 mjeseca, a nakon toga svakih 8 tjedana.
English: Treatment intervals greater than four months between injections have not been studied (see Section
Croatian: Razdoblja između injekcija dulja od četiri mjeseca nisu ispitivana (vidjeti dio 5.1).
English: In the VISTADME study, 217 (70.7%) of Eylea patients received bilateral Eylea injections until week100; in the VIVIDDME study, 97 (35.8%) of Eylea patients received a different anti-VEGF treatment in their fellow eye.
Croatian: U ispitivanju VISTADME, 217 (70,7%) bolesnika liječenih lijekom Eylea bilateralno je primalo injekcije lijeka Eylea do 100. tjedna; u ispitivanju VIVIDDME, 97 (35,8%) bolesnika liječenih lijekom Eylea primalo je različito anti-VEGF liječenje za drugo oko.
English: wet AMD
Croatian: Vlažni AMD
English: The fixed regimen for Eylea rescue was three times Eylea 2mg every 4 weeks followed by injections every 8 weeks.
Croatian: Utvrđeni režim za primjenu Eylea spasonosnog liječenja bio je tri puta 2 mg lijeka Eylea svaka 4 tjedna nakon kojih su slijedile injekcije svakih 8 tjedana.
English: 52 Weeks
Croatian: 52 tjedna
English: The safety data described below include all adverse reactions from the eight phase III studies in the indications wet AMD, CRVO, BRVO, DME and myopic CNV with a reasonable possibility of causality to the injection procedure or medicinal product.
Croatian: Niže opisani podaci o sigurnosti primjene uključuju sve nuspojave iz osam ispitivanja faze III u indikacijama vlažnog AMD-a, CRVO-a, BRVO-a, DME-a i miopijskog CNV-a s razumnom mogućnošću da su uzročno-posljedično povezane s postupkom davanja injekcije ili lijekom.
English: 90 microlitres of solution in pre-filled syringe (type I glass) marked with a black dosing line, with a plunger stopper (elastomeric rubber) and a Luer lock adaptor with a tip cap (elastomeric rubber).
Croatian: 90 mikrolitara otopine u napunjenoj štrcaljki (staklo tipa I) označenoj crnom doznom oznakom, s čepom klipa (elastomerna guma) i Luer lock nastavkom sa zatvaračem vrha (elastomerna guma).
English: Remove the plastic cap and disinfect the outer part of the rubber stopper of the vial.
Croatian: Uklonite plastični zatvarač i dezinficirajte vanjski dio gumenog čepa bočice.
English: A decision must be made whether to discontinue breast-feeding or to abstain from Eylea therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman
Croatian: Potrebno je odlučiti da li prekinuti dojenje ili prekinuti liječenje lijekom Eylea, uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu
English: A decision must be made whether to discontinue breast-feeding or to abstain from Eylea therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Croatian: Potrebno je odlučiti da li prekinuti dojenje ili prekinuti liječenje lijekom Eylea, uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
English: Table 2: Efficacy outcomes at week 52 (primary analysis) and week 96; combined data from the VIEW1 and VIEW2 studiesB)
Croatian: Tablica 2: Ishodi djelotvornosti u 52. tjednu (primarna analiza) i 96. tjednu; kombinirani podaci iz ispitivanja VIEW1 i VIEW2B)
English: 1 ml solution for injection contains 40 mg aflibercept*.
Croatian: 1 ml otopine za injekciju sadrži 40 mg aflibercepta*.
English: Patients in the sham group were eligible to receive Eylea from week 24.
Croatian: Bolesnici u skupini s placebo postupkom bili su pogodni za primanje lijeka Eylea od 24. tjedna.
English: Eylea is a solution for injection (injection) in a vial (4 mg/100 microlitres).
Croatian: Eylea je otopina za injekciju (injekcija) u bočici (4 mg/100 mikrolitara).
English: The reduction of CNV size and reduction in CRT were generally maintained in the second year of the studies.
Croatian: Smanjenje veličine patološke neovaskularizacije žilnice i smanjenje CRT-a općenito su bili održani u drugoj godini kliničkih ispitivanja.
English: • Eylea is not recommended during breast-feeding.
Croatian: • Lijek Eylea ne preporučuje se tijekom dojenja.
English: The difference between treatment groups was statistically significant in favour of Eylea for the primary endpoint (change in BCVA) and confirmatory secondary efficacy endpoint (proportion of patients who gained 15 letters in BCVA) at week 24 compared to baseline.
Croatian: Razlika između terapijskih skupina bila je statistički značajna u korist lijeka Eylea u primarnom ishodu (promjena BCVA-a) i konfirmatornom sekundarnom ishodu djelotvornosti (udio bolesnika u kojih se BCVA povećao za 15 slova) u 24. tjednu u usporedbi s početnom vrijednošću.
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.
Croatian: Da biste uklonili zatvarač sa štrcaljke, držite štrcaljku jednom rukom, a palcem i kažiprstom druge ruke uhvatite zatvarač štrcaljke.
English: Effects on male and female fertility were assessed as part of a 6-month study in monkeys with intravenous administration of aflibercept at doses ranging from 3 to 30 mg/kg.
Croatian: Učinci na plodnost u mužjaka i ženki procijenjeni su u sklopu šestomjesečnog ispitivanja na majmunima koji su dobivali intravenski primijenjen aflibercept u rasponu doza od 3 do 30 mg/kg.
English: Aflibercept, the active substance in Eylea, blocks the activity of a group of factors, known as Vascular Endothelial Growth Factor A (VEGF-A) and Placental Growth Factor (PlGF).
Croatian: Aflibercept, djelatna tvar u lijeku Eylea, blokira aktivnost skupine čimbenika koji se zovu vaskularni endotelni čimbenik rasta A (VEGF-A) i placentni čimbenik rasta (PlGF).
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.
Croatian: U posljednjem posjetu prije 96. tjedna, 64,9% bolesnika u skupini s 2-tjednim i 61,2% u skupini s 4-tjednim intervalima prilagodbe imali su planiranu sljedeću injekciju u razmaku od 12 tjedana ili nakon toga.
English: There is a theoretical risk of arterial thromboembolic events, including stroke and myocardial infarction, following intravitreal use of VEGF inhibitors.
Croatian: Postoji teoretski rizik od arterijskih tromboembolijskih događaja, uključujući moždani udar i infarkt miokarda, a nakon intravitrealne primjene VEGF inhibitora.
English: What you need to know before you are given Eylea
Croatian: Što morate znati prije nego počnete primati lijek Eylea
English: A positive value favours Eylea.
Croatian: Pozitivna razlika govori u prilog lijeku Eylea.
English: • The dose should be withheld and treatment should not be resumed earlier than the next scheduled treatment in the event of: o a decrease in best-corrected visual acuity (BCVA) of ≥30 letters compared with the last assessment of visual acuity; o a subretinal haemorrhage involving the centre of the fovea, or, if the size of the haemorrhage is ≥50%, of the total lesion area.
Croatian: • Doza se ne smije primijeniti i ne smije se nastaviti s liječenjem prije sljedećeg planiranog liječenja u slučaju: slabljenja najbolje korigirane oštrine vida (BCVA) za ≥ 30 slova u usporedbi sa zadnjim nalazom oštrine vida; subretinalnog krvarenja koje zahvaća sredinu foveje ili, ako je veličina krvarenja
English: Eylea is a solution for injection (injection) in a pre-filled syringe (3.6 mg/90 microlitres).
Croatian: Eylea je otopina za injekciju (injekcija) u napunjenoj štrcaljki (3,6 mg/90 mikrolitara).
English: In the second year of the studies, patients continued to receive the initially randomised dosage but on a modified dosing schedule guided by assessment of visual and anatomic outcomes with a protocoldefined maximum dosing interval of 12 weeks.
Croatian: U drugoj godini ispitivanja bolesnici su nastavili primati dozu koja im je bila nasumično dodijeljena na početku, ali prema prilagođenom rasporedu doziranja određenom prema vizualnim i anatomskim ishodima uz maksimalni interval doziranja od 12 tjedana definiran planom ispitivanja.
English: Up-regulation of VEGF is associated with the breakdown of the blood retina barrier, increased vascular permeability, retinal oedema, and neovascularisation complications.
Croatian: Regulacija naviše VEGF-a povezana je s raspadom barijere između krvi i mrežnice, povećanom vaskularnom permeabilnošću, edemom mrežnice i komplikacijama neovaskularizacije.
English: A,C)
Croatian: E,F)
English: There are limited data on safety in treating patients with CRVO, BRVO, DME and myopic CNV who have had a stroke or a mini-stroke (transient ischaemic attack) or a heart attack within the last 6 months.
Croatian: Postoje ograničeni podaci o sigurnosti primjene kod liječenja bolesnika s CRVO-om, BRVO-om, DME-om i miopijskim CNV-om koji su imali moždani udar ili mini-moždani udar (tranzitornu ishemijsku ataku) ili srčani udar u prethodnih 6 mjeseci.
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.
Croatian: G) U ispitivanju GALILEO, i kontrolna skupina i bolesnici liječeni s Eylea od 2 mg primali su lijek Eylea od 2 mg na temelju potrebe svakih 8 tjedana počevši od 52. do 68. tjedna; bolesnici su dolazili na obavezne kontrolne preglede svakih 8 tjedana.
English: The use of Eylea in children or adolescents under 18 has not been studied because wet AMD, CRVO, BRVO, DME and myopic CNV occur mainly in adults.
Croatian: Primjena lijeka Eylea u djece i adolescenata mlađih od 18 godina nije ispitana zato što vlažni AMD, CRVO, BRVO, DME i miopijski CNV nastaju uglavnom u odraslih osoba.
English: All patients received monthly doses of Eylea 2 mg for 3 months, followed by one injection after a further 2 month interval.
Croatian: Svi bolesnici su primili mjesečne doze lijeka Eylea od 2 mg tijekom 3 mjeseca, te potom jednu injekciju nakon sljedeća 2 mjeseca.
English: 100 microlitres of solution in a vial (type I glass) with a stopper (elastomeric rubber), and an 18 G filter needle.
Croatian: 100 mikrolitara otopine u bočici (staklo tipa I) s čepom (elastomerna guma) i jedna filtar-igla od 18 G.
English: Do not open the sterile pre-filled blister outside the clean administration room.
Croatian: Ne otvarajte sterilni napunjeni blister izvan prostorije s uvjetima koji osiguravaju čistu primjenu.
English: D) Confidence interval (CI) calculated by normal approximation E) After treatment initiation with three monthly doses F) A confidence interval lying entirely above -10% indicates a non-inferiority of Eylea to ranibizumab
Croatian: E) Nakon početka liječenja uz tri mjesečne doze F) Interval pouzdanosti koji je potpuno iznad -10% pokazuje da Eylea nije inferiorna ranibizumabu
English: Carefully peel open the blister ensuring the sterility of its contents.
Croatian: Pažljivo otvorite blister, pazeći na sterilnost sadržaja.
English: Since the pre-filled syringe contains more volume (90 microlitres) than the recommended dose (50 microlitres), a part of the volume contained in the syringe has to be discarded prior to the administration.
Croatian: Budući da napunjena štrcaljka sadrži veći volumen (90 mikrolitara) od preporučene doze (50 mikrolitara), prije primjene potrebno je istisnuti dio volumena iz štrcaljke.
English: Unless you experience any problems or are advised differently by your doctor, there is no need for you to see your doctor between the injections.
Croatian: Nema potrebe da posjećujete liječnika između injekcija, osim ako ćete imati neke tegobe ili će Vam liječnik savjetovati drugačije.
English: Figure 5:
Croatian: Slika 5:
English: 24 Weeks
Croatian: 24 tjedna
English: - diabetics with very high average blood sugar values (HbA1c over 12%).
Croatian: I - osoba sa šećernom bolešću s vrlo visokim prosječnim vrijednostima šećera u krvi (HbA1c veći od
English: A low incidence rate of arterial thromboembolic events was observed in the Eylea clinical trials in patients with AMD, DME, RVO and myopic CNV.
Croatian: Opažena je niska stopa incidencije arterijskih tromboembolijskih događaja u kliničkim ispitivanjima s lijekom Eylea u bolesnika s AMD-om, DME-om, RVO-om i miopijskim CNV-om.
English: STATEMENT OF ACTIVE SUBSTANCE Aflibercept
Croatian: NAVOĐENJE DJELATNE TVARI aflibercept
English: During the second year of treatment patients in both the 2-week and 4-week adjustment groups received an average of 3.6 and 3.7 injections, respectively.
Croatian: Tijekom druge godine liječenja, bolesnici u 2-tjednom intervalu prilagodbe primili su prosječno 3,6 injekcija, a 4-tjednom intervalu prilagodbe 3,7 injekcija.
English: Delivers a single dose of 2 mg/0.05 ml.
Croatian: Za pojedinačnu dozu od 2 mg/0,05 ml.
English: Your doctor may decide to stop treatment with Eylea if it is determined that you are not benefiting from continued treatment.
Croatian: Vaš liječnik može odlučiti prekinuti liječenje lijekom Eylea ukoliko je siguran da nemate dobrobiti od nastavka liječenja.
English: When ready to administer Eylea, open the carton and remove the sterilized blister.
Croatian: Kad budete spremni primijeniti lijek Eylea, otvorite kutiju i izvadite sterilizirani blister.
English: Instructions for use of vial:
Croatian: Upute za uporabu bočice:
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.
Croatian: Kao odgovor na to povisuju se razine VEGF-a uzrokujući prodor tekućine u mrežnicu i stoga oticanje makule (dio mrežnice odgovoran za jasan vid), zbog čega se to zove makularni edem.
English: If visual and/or anatomic outcomes deteriorate, the treatment interval should be shortened accordingly to a minimum of two months during the first 12 months of treatment.
Croatian: Ako se vizualni i/ili anatomski ishodi pogoršaju, razmake između doza treba skratiti sukladno tome, ali ne na kraće od svaka dva mjeseca tijekom prvih 12 mjeseci liječenja.
English: For the intravitreal injection, a 30 G x ½ inch injection needle should be used.
Croatian: Za intravitrealnu injekciju potrebno je uporabiti iglu za injekciju od 30 G x 12,7 mm.
English: In patients with BRVO, one or more branches of the main blood vessel that transports blood away from the retina is blocked.
Croatian: U bolesnika s BRVO-om, jedan ili više ogranaka glavne krvne žile koja odvodi krv iz mrežnice je blokiran.
English: You will start your treatment with a series of monthly Eylea injections.
Croatian: Liječenje ćete započeti serijom injekcija lijeka Eylea svaki mjesec.
English: Since the vial contains more volume (100 microlitres) than the recommended dose (50 microlitres), a part of the volume contained in the vial has to be discarded prior to the administration.
Croatian: Budući da bočica sadrži veći volumen (100 mikrolitara) od preporučene doze (50 mikrolitara), prije primjene potrebno je istisnuti dio volumena iz bočice.
English: This provides a usable amount to deliver a single dose of 50 microlitres containing 2 mg aflibercept.
Croatian: To osigurava iskoristivu količinu za primjenu jedne doze od 50 mikrolitara koja sadrži 2 mg aflibercepta.
English: The systemic use of VEGF inhibitors, substances similar to those contained in Eylea, is potentially related to the risk of blood clots blocking blood vessels (arterial thromboembolic events) which may lead to heart attack or stroke.
Croatian: Postoji mogućnost da je sistemska primjena inhibitora VEGF-a, tvari koje su slične onima koje sadrži Eylea, povezana s rizikom od začepljenja krvnih žila krvnim ugrušcima (arterijski tromboembolijski događaji), što može dovesti do srčanog ili moždanog udara.
English: After injection any unused product must be discarded.
Croatian: Nakon primjene injekcije, neprimijenjeni lijek mora se zbrinuti.
English: The maternal NOAEL was at the dose of 3 mg/kg or 1 mg/kg, respectively.
Croatian: NOAEL za skotne ženke bila je doza od 3 mg/kg odnosno 1 mg/kg.
English: In patients treated with Eylea in the MYRROR study (one injection given at start of therapy, with additional injections given in case of disease persistence or recurrence), CRT decreased soon after treatment initiation favouring Eylea at week 24 (-79 microns and -4 microns for the Eylea 2 mg treatment group and the control group, respectively), which was maintained through week 48.
Croatian: U bolesnika liječenih lijekom Eylea u ispitivanju MYRROR (jedna injekcija dana na početku terapije, a dodatne injekcije dane u slučaju trajanja ili recidiva bolesti), CRT se smanjio ubrzo nakon početka liječenja, u korist lijeka Eylea u 24. tjednu (-79 mikrometara za skupinu liječenu lijekom Eylea 2 mg i -4 mikrometra za kontrolnu skupinu), što je zadržano kroz 48. tjedan.
English: 1) Eylea administered at 2 mg every 8 weeks following 3 initial monthly doses (Eylea 2Q8); 2) Eylea administered at 2 mg every 4 weeks (Eylea 2Q4);
Croatian: 1) Eylea primijenjena u dozi od 2 mg svakih 8 tjedana nakon 3 početne mjesečne doze (Eylea 2Q8); 2) Eylea primijenjena u dozi od 2 mg svaka 4 tjedna (Eylea 2Q4);
English: Ensure that the plunger rod is drawn sufficiently back when emptying the vial in order to completely empty the filter needle.
Croatian: Pazite da dovoljno izvučete klip dok praznite bočicu, kako biste potpuno ispraznili filtar-iglu.
English: Serious ocular adverse reactions in the study eye related to the injection procedure have occurred in less than 1 in 1,900 intravitreal injections with Eylea and included blindness, endophthalmitis, retinal detachment, cataract traumatic, cataract, vitreous haemorrhage, vitreous detachment, and intraocular pressure increased (see section 4.4).
Croatian: Ozbiljne očne nuspojave u ispitivanom oku povezane s postupkom davanja injekcije pojavile su se u manje od 1 na 1900 intravitrealnih injekcija lijeka Eylea, a uključivale su sljepoću, endoftalmitis, odignuće mrežnice, traumatsku kataraktu, kataraktu, krvarenje u staklovinu, odignuće staklovine i povećanje intraokularnog tlaka (vidjeti dio 4.4).
English: 3) Eylea administered at 0.5 mg every 4 weeks (Eylea 0.5Q4); and 4) ranibizumab administered at 0.5 mg every 4 weeks (ranibizumab 0.5Q4).
Croatian: 3) Eylea primijenjena u dozi od 0,5 mg svaka 4 tjedna (Eylea 0,5Q4); i 4) ranibizumab primijenjen u dozi od 0,5 mg svaka 4 tjedna (ranibizumab 0,5Q4).
English: - The other ingredients are: polysorbate 20, sodium dihydrogen phosphate monohydrate (for pH adjustment), disodium hydrogen phosphate heptahydrate (for pH adjustment), sodium chloride, sucrose, water for injection.
Croatian: - Drugi sastojci su: polisorbat 20, natrijev dihidrogenfosfat hidrat (za podešavanje pH), natrijev hidrogenfosfat heptahidrat (za podešavanje pH), natrijev klorid, saharoza, voda za injekcije.
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.
Croatian: U oba ispitivanja, primarni ishod djelotvornosti bio je udio bolesnika liječenih prema protokolu u kojih se zadržao vid, tj. gubitak manje od 15 slova oštrine vida u 52. tjednu od početne vrijednosti.
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).
Croatian: Udio bolesnika koji nisu izgubili ≥15 slova u dvije liječene skupine bio je sličan (96,7% u skupini s 2-tjednom te 95,9% u skupini s 4-tjednom prilagodbom).