natgillin/translations-raw huggingface dataset:
Repeat doses should be considered when a patient experiences a response to treatment followed subsequently by a loss in visual acuity and in the physician's opinion may benefit from retreatment without being exposed to significant risk (see section 5.1). 
Potrebno je razmotriti ponavljanje doze kada bolesnik osjeti reakciju na liječenje nakon koje slijedi smanjenje oštrine vida i ako mu, prema mišljenju liječnika, ponovljeni tretman može koristiti, a da nije izložen značajnom riziku (vidjeti dio 5.1).
Escape therapy was permitted at the investigators discretion at any stage but led to subsequent withdrawal from the studies. 
Liječenje u slučaju neuspjeha tretmana bilo je dozvoljeno prema diskrecionom pravu ispitivača u bilo kojem stadiju ispitivanja, ali je to dovelo do isključivanja ispitanika iz daljnjeg ispitivanja.
The rate and magnitude of IOP elevation following OZURDEX treatment did not increase upon repeated injection of OZURDEX. 
Stopa i veličina porasta IOT-a nakon injekcije lijeka OZURDEX nije rasla s ponavljanjem injekcija lijeka OZURDEX.
After OZURDEX treatment you may experience some reduced vision for a short time. 
Nakon ubrizgavanja lijeka OZURDEX možete kratkotrajno iskusiti oslabljeni vid.
• Vision loss due to diabetic macular oedema (DME), if you have already had an operation for cataract, or if you have not previously responded to, or are not suitable for, other types of treatment. 
• gubitkom vida zbog dijabetičkog makularnog edema (DME), ako ste već operirali kataraktu ili ranije niste imali pozitivan odgovor ili niste bili prikladan kandidat za druge oblike liječenja.
Long-term systemic treatment with glucocorticoids during pregnancy increases the risk for intra-uterine growth retardation and adrenal insufficiency of the newborn child. 
Dugotrajna sistemska terapija glukokortikosteroidima tijekom trudnoće povećava rizik od intrauterinog zaostajanja u rastu ploda i adrenalne insuficijencije kod novorođenčeta.
The intravitreal injection procedure should be carried out under controlled aseptic conditions which include the use of sterile gloves, a sterile drape, and a sterile eyelid speculum (or equivalent). 
Postupak intravitrealnog ubrizgavanja treba se provesti u kontroliranim aseptičnim uvjetima koji uključuju uporabu sterilnih rukavica, sterilnog prekrivača i sterilnog spekuluma za vjeđu (ili drugu odgovarajuću opremu).
The patient information pack should be provided in both the form of patient information booklet and an audio-CD that contain following key elements: 
Komplet informacija za bolesnika mora biti u obliku brošure i u obliku CD audio zapisa te mora sadržavati sljedeće ključne elemente:
The applicator and a packet of drying material are sealed in a foil pouch which is inside a carton. 
Aplikator i paketić sa sredstvom za sušenje hermetički su zatvoreni u vrećici koja se nalazi unutar kartonske kutije.
Before withdrawing the applicator from the eye, make sure that the actuator button is fully pressed and has locked flush with the applicator surface. 
Prije izvlačenja aplikatora iz oka, provjerite da je gumb za aktivaciju u potpunosti pritisnut i da je čvrsto zaglavljen u ravnini s površinom aplikatora.
Therefore OZURDEX is not recommended. 
Stoga se uporaba lijeka OZURDEX ne preporučuje.
The recommended dose is one implant to be given by injection into your eye. 
Preporučena doza je jedan implantat koji se primjenjuje ubrizgavanjem u oko.
By Day 180 the mean retinal thickness reduction (-119.3 microns) compared with sham was not significant. 
Na 180. dan prosječno smanjenje debljine mrežnice (-119,3 mikrona) u usporedbi s placebo postupkom nije bilo značajno.
The incidence of increased IOP (24.9 %) was similar to that seen following the first injection and likewise returned to baseline by open-label day 180. 
Incidencija povišenog očnog tlaka (24,9%) bila je slična onoj nakon prvog ubrizgavanja te se on također vratio na početnu razinu do 180. dana otvorenog ispitivanja.
RVO and uveitis 
RVO i uveitis
If a patient presents with symptoms such as blurred vision or other visual disturbances, consider evaluating for possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids. 
Ako se u bolesnika pojave simptomi poput zamagljenog vida ili drugih smetnji vida, razmotrite procjenu mogućih uzroka koji mogu uključivati kataraktu, glaukom ili rijetke bolesti poput središnje serozne korioretinopatije (engl. central serous chorioretinopathy, CSCR), koji su prijavljeni nakon sistemske i topikalne primjene kortikosteroida.
Dexamethasone exposure to the healthy/untreated eye via contralateral diffusion has been observed in rabbits following delivery of the implant to the posterior segment of the eye. 
Izlaganje deksametazonu kod zdravog/neliječenog oka putem kontralateralne difuzije primijećeno je kod zečeva nakon postavljanja implantata u stražnji segment oka.
There are no adequate data from the use of intravitreally administered dexamethasone in pregnant women. 
Ne postaje adekvatni podaci o uporabi intravitrealno primijenjenog deksametazona kod trudnica.
Corticosteroids have been shown to inhibit the expression of VEGF. 
Dokazano je da kortikosteroidi mogu inhibirati ekspresiju
Clinical efficacy and safety Diabetic Macular Oedema 
Klinička djelotvornost i sigurnost Dijabetički makularni edem
Monitoring may consist of a check for perfusion of the optic nerve head immediately after the injection, tonometry within 30 minutes following the injection, and biomicroscopy between two and seven days following the injection. 
Promatranje se može sastojati od provjere perfuzije glave vidnog živca odmah nakon ubrizgavanja, tonometrije u roku od 30 minuta nakon injiciranja te biomikroskopije između dva i sedam dana nakon injiciranja.
This could be attributable to the intravitreous injection procedure or to concomitant use of topical and/or systemic corticosteroid or Non-steroidal anti-inflammatory medications. 
To bi se moglo pripisati postupku intravitrealnog ubrizgavanja ili istovremenoj topikalnoj i/ili sistemskoj primjeni kortikosteroida ili nesteroidnih protuupalnih lijekova.
Carefully remove the cap from the applicator. 
Pažljivo skinite zatvarač s aplikatora.
Very common (≥ 1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 
vrlo često ((≥1/10), često (≥1/100 i <1/10), manje često (≥1/1000 i <1/100), rijetko (≥1/10 000 i
Intravitreal use. 
Intravitrealna uporaba.
As expected with ocular steroid treatment and intravitreal injections, increases in intraocular pressure (IOP) may be seen. 
Kao što se može i očekivati kod liječenja oka steroidima i intravitrealnih injekcija, može doći do povišenja intraokularnog tlaka (IOT).
This can lead to swelling of the clear layer in the front of the eye and cause blurred vision. 
To može dovesti do oteknuća prozirnog sloja prednjeg dijela oka i biti uzrok zamućenog vida.
The needle is protected by a cap and the lever by a safety tab. 
Igla je zaštićena zatvaračem (kapicom), a poluga sigurnosnom pločicom.
One carton contains one applicator with one implant which will be used once and thrown away. 
Jedna kartonska kutija sadrži jedan aplikator s jednim implantatom za jednokratnu uporabu, nakon koje aplikator treba baciti.
Occasionally the injection of OZURDEX may cause an infection inside the eye, pain or redness in the eye, or a detachment or tear of the retina. 
Ponekad injekcija lijeka OZURDEX može izazvati infekciju u oku, bol ili crvenilo u oku, ili odljepljivanje ili puknuće mrežnice.
Then, in a sterile field, open the foil pouch and gently place the applicator on a sterile tray. 
Nakon toga, u sterilnom polju otvorite vrećicu i pažljivo stavite aplikator na sterilni pladanj.
PHARMACEUTICAL PARTICULARS 6.6 Special precautions for disposal and other handling 
FARMACEUTSKI PODACI 6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom
The patient should be instructed to self-administer broad spectrum antimicrobial drops daily for 3 days before and after each injection. 
Bolesnika treba uputiti da si sam svakodnevno ukapava u oko antibiotske kapi širokog spektra, tijekom 3 dana prije i 3 dana nakon svakog injiciranja.
A total of 401 patients (94 %) randomised and treated with OZURDEX completed the initial treatment period (up to day 180). 
Ukupno 401 bolesnik (94%) odabran slučajnim odabirom i liječen lijekom OZURDEX dovršio je početno razdoblje liječenja (do 180. dana).
The injection of OZURDEX into both eyes at the same time has not been studied and is not recommended. 
Ubrizgavanje lijeka OZURDEX u oba oka istovremeno nije ispitivano i nije preporučljivo.
Vitreous haemorrhage was reported in a higher proportion of patients treated with OZURDEX who received anti-coagulant therapy (11%) compared with those not receiving anticoagulant therapy (6%). 
Krvarenja u staklovinu zabilježena su u većoj mjeri u bolesnika liječenih lijekom OZURDEX koji su primali antikoagulantnu terapiju (11%) u usporedbi s onima koji takvu terapiju nisu primali (6%).
• Key signs and symptoms of serious adverse events including: worsening of vision after the injection; pain or discomfort in or around the eye, redness of the eye which continues to get worse; increase in floaters or spots in the vision; discharge from the eye 
• Glavne znakove i simptome ozbiljnih štetnih događaja, uključujući: pogoršanje vida nakon injekcije; bol ili nelagodu u oku ili oko oka; crvenilo oka koje se i dalje pogoršava; povećan broj opaciteta ili točkica u vidnom polju; iscjedak iz oka.
The rise in IOP is normally manageable with IOP lowering medication (see section 4.8). 
Porast IOT-a obično se može kontrolirati lijekovima za snižavanje IOT (vidjeti dio 4.8).
Patients who experience and retain improved vision should not be retreated. 
Bolesnicima kod kojih se poboljšanje vida pojavi i zadrži, ne bi trebalo ponavljati tretman.
The reduction in vitreous haze was accompanied by an improvement in visual acuity. 
Smanjenje zamućenosti staklastog tijela popraćeno je poboljšanom oštrinom vida.
Sham N = 261 P-value 
Placebo N = 261 P-vrijednost
Remove the foil pouch from the carton and examine for damage (see section 6.6). 
Izvadite vrećicu iz kartonske kutije te provjerite postoje li oštećenja (vidjeti dio 6.6).
Mean IOP in the study eye at baseline was the same in both treatment groups (15.3 mmHg). 
Srednji IOT u ispitivanom oku na početku ispitivanja bio je jednak u obje ispitivane skupine (15,3 mmHg).
Use of corticosteroids, including OZURDEX, may induce cataracts (including posterior subcapsular cataracts), increased IOP, steroid induced glaucoma and may result in secondary ocular infections. 
Uporaba kortikosteroida, uključujući OZURDEX, može inducirati nastanak katarakte (uključujući stražnju supkapsularnu kataraktu), povišeni IOT, steroidima inducirani glaukom i može prouzročiti sekundarne infekcije oka.
If an overdose occurs, intraocular pressure should be monitored and treated, if deemed necessary by the attending physician. 
Ako dođe do predoziranja, potrebno je pratiti očni tlak te ga liječiti, ako prisutan liječnik smatra da je to potrebno.
Patients who experience deterioration in vision, which is not slowed by OZURDEX, should not be retreated. 
Bolesnicima kod kojih se javi pogoršanje vida koje nije usporeno lijekom OZURDEX, ne bi trebalo ponavljati tretman.
Implant migration to the anterior chamber may lead to corneal oedema. 
Migracija implantata u prednju očnu sobicu može dovesti do edema rožnice.
4) Depress the actuator button slowly until you hear a click. 
4) Polako pritišćite gumb za aktivaciju dok ne čujete „klik”.
Of the patients experiencing an increase of IOP of ≥10 mmHg from baseline, the greatest proportion showed this IOP increase between 45 and 60 days following an injection. 
Od bolesnika kod kojih se pojavio porast IOT od ≥10 mmHg u odnosu na početnu vrijednost, u većini slučajeva taj se porast pojavio između 45 i 60 dana nakon injiciranja.
Table 1 Adverse reactions System organ class 
Tablica 1 Nuspojave Klasifikacija organskih sustava
In RVO, anti-coagulant therapy was used in 2% of patients receiving OZURDEX; there were no reports of haemorrhagic adverse events in these patients. 
Kod RVO, antikoagulantna terapija korištena je u 2% bolesnika koji su primili OZURDEX; nije bilo prijava hemoragijskih štetnih događaja kod tih bolesnika.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS APPLICATOR LABEL 
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA APLIKATORU
Dexamethasone remained detectable in the vitreous at 6 months post-injection. 
Deksametazon je i dalje bilo moguće pronaći u staklastom tijelu 6 mjeseci nakon ubrizgavanja.
The efficacy of OZURDEX was assessed in two 3 year, multicentre, double-masked, randomised, sham-controlled, parallel studies of identical design which together comprised 1,048 patients (studies 206207-010 and 206207-011). 
Djelotvornost lijeka OZURDEX ocjenjivana je dvama trogodišnjim, multicentričnim, dvostruko maskiranim, randomiziranim, placebom kontroliranim paralelnim ispitivanjima identičnima po dizajnu, tijekom kojih je uspoređivano 1048 bolesnika (ispitivanja 206207-010 i 206207-011).
Remove the needle in the same direction as used to enter the vitreous. 
Izvucite iglu u istom smjeru koji je korišten za ulazak u staklasto tijelo.
Increased pressure in the eye, clouding of the lens (cataract), bleeding on the surface of the eye* 
Porast tlaka u oku, zamućenje leće (mrena), krvarenje na površini oka*
The safety and efficacy of OZURDEX in uveitis in the paediatric population have not been established. 
Sigurnost i djelotvornost lijeka OZURDEX u slučaju uveitisa u pedijatrijskoj populaciji nisu ustanovljene.
INFORMATION FOR THE HEALTHCARE PROFESSIONAL NAME OF THE MEDICINAL PRODUCT 
PODACI ZA ZDRAVSTVENOG RADNIKA NAZIV LIJEKA
Patients treated with OZURDEX who have experienced an initial response and in the physician's opinion may benefit from retreatment without being exposed to significant risk should be considered for retreatment. 
DME U bolesnika liječenih lijekom OZURDEX koji su imali prvotni odgovor na primjenu, a po mišljenju liječnika mogli bi imati koristi od ponovne primjene bez da budu izloženi značajnom riziku, potrebno je razmotriti ponovnu primjenu.
• Inflammation of the back of the eye. 
• upalom stražnjeg dijela oka.
Dexamethasone is ultimately metabolised to lipid and water soluble metabolites that can be excreted in bile and urine. 
Deksametazon se u konačnici metabolizira u lipide i metabolite koji su topivi u vodi i koji mogu biti izlučeni putem žuči i mokraće.
All patients with posterior capsule tear, such as those with a posterior lens (e.g. due to cataract surgery), and/or those who have an iris opening to the vitreous cavity (e.g. due to iridectomy) with or without a history of vitrectomy, are at risk of implant migration into the anterior chamber. 
Kod svih bolesnika s rupturom stražnje kapsule leće, poput onih sa stražnjom lećom (npr. zbog operacije katarakte) i/ili onih koji imaju otvor na šarenici koji dopire do očne jabučice (npr. zbog iridektomije) sa ili bez vitrektomije u anamnezi, postoji opasnost od migracije implantata u prednju očnu sobicu.
Diabetic macular oedema is a swelling of the light-sensitive layer at the back of the eye called the macula. 
Dijabetički makularni edem je zadebljanje na svjetlo osjetljivog sloja u stražnjem dijelu oka koji se naziva makula.
Once the foil pouch is opened the applicator should be used immediately. 
Kada otvorite vrećicu potrebno je odmah upotrijebiti aplikator.
Before the injection, the periocular skin, eyelid and ocular surface should be disinfected (using for example drops of povidone iodine 5% solution on the conjunctiva as it was done in the clinical trials for the approval of OZURDEX) and adequate local anaesthesia should be administered. 
Prije injiciranja treba dezinficirati kožu oko oka, vjeđu i površinu oka (korištenjem na primjer kapi 5% otopine povidon-joda u spojnicu (konjunktivu) kako je činjeno u kliničkim ispitivanjima za odobrenje lijeka OZURDEX) te primijeniti odgovarajuću lokalnu anesteziju.
Vascular Endothelial Growth Factor (VEGF) is a cytokine which is expressed at increased concentrations in the setting of macular oedema. 
Vascular Endothelial Growth Factor) je citokin koji je eksprimiran u povišenim koncentracijama u okolnostima makularnog edema.
For instructions on the administration of the intravitreal implant, see section 6.6 
Za upute za primjenu intravitrealnog implantata vidjeti dio 6.6.
OZURDEX was numerically superior to sham in preventing vision loss as shown by a lower of proportion of patients experiencing deterioration of vision of ≥ 15 letters in the OZURDEX group throughout the 6-month assessment period. 
OZURDEX je brojčano bio superioran placebo postupku u sprječavanju gubitka vida što se pokazuje manjim udjelom bolesnika kod kojih se javilo pogoršanje vida od ≥ 15 slova u skupini liječenoj lijekom OZURDEX tijekom razdoblja procjene od 6 mjeseci.
Push the tip about 1 mm into the sclera, keeping it parallel to the limbus. 
Gurnite vršak igle otprilike 1 mm u bjeloočnicu tako da ulazi paralelno u odnosu na limbus.
The most frequently reported adverse reactions across the entire study period in the study eye of patients who received OZURDEX were cataract and elevated IOP (see below). 
Najčešće prijavljene nuspojave na ispitivanom oku tijekom čitavog razdoblja ispitivanja u bolesnika koji su primili OZURDEX bile su katarakta i povišeni IOT (vidjeti u nastavku).
In the non-infectious uveitis study, 1 patient out of the 62 phakic patients underwent cataract surgery after a single injection. 
U kliničkim studijama neinfektivnog uveitisa, 1 bolesnik od 62 bolesnika s fakičnim lećama podvrgnut je operaciji katarakte nakon jednog ubrizgavanja.
However OZURDEX is not recommended during breast feeding unless clearly necessary. 
Međutim, OZURDEX se ne preporučuje tijekom dojenja osim u slučaju da je to izričito potrebno.
** in a 24-month real world observational study in the treatment of macular oedema following RVO and noninfectious uveitis affecting the posterior segment of the eye these adverse events were reported more frequently among patients who received >2 injections vs patients who received ≤2 injections; cataract formation (24.7% vs 17.7%), cataract progression (32.0% vs 13.1%), vitreous haemorrhage (6.0% vs 2.0%), and increased IOP (24.0% vs 16.6%). 
** u 24-mjesečnom opservacijskom ispitivanju, u stvarnom životu, liječenja makularnog edema nakon RVO i neinfektivnog uveitisa stražnjeg segmenta oka, ove su nuspojave prijavljivane češće u bolesnika koji su primili >2 injekcije u usporedbi s bolesnicima koji su primili ≤2 injekcije; formiranje katarakte (24,7% naspram 17,7%), progresija katarakte (32,0% naspram 13,1%), vitrelno krvarenje (6,0% naspram 2,0%) i povišeni IOP (24,0% naspram 16,6%).
A limited number of subjects with Type 1 diabetes were investigated in the Phase 3 studies, and the response to OZURDEX in these subjects was not significantly different to those subjects with Type 2 diabetes. 
Ograničeni broj ispitanika s dijabetesom tipa 1 ispitivan je u ispitivanjima faze 3, a odgovor tih ispitanika na OZURDEX nije bio značajno različit od odgovora ispitanika s dijabetesom tipa 2.
In an in vitro metabolism study, following the incubation of [14C]-dexamethasone with human cornea, iris-ciliary body, choroid, retina, vitreous humour, and sclera tissues for 18 hours, no metabolites were observed. 
U in vitro studiji metabolizma, nakon inkubacije [14C]-deksametazona u rožnici, šarenici-zrakastom tijelu, žilnici, mrežnici, staklastom tijelu i tkivu bjeloočnice ljudi, tijekom 18 sati nisu primijećeni metaboliti.
Day 180 a Proportion significantly higher with OZURDEX compared to sham (p < 0.001) 
Dan 180 a Udio značajno viši kod lijeka OZURDEX u usporedbi s placebo postupkom (p < 0,001)
With the exception of headache and migraine, no systemic adverse drug reactions were identified with the use of OZURDEX. 
Uz izuzetak glavobolje i migrene, kod primjene lijeka OZURDEX nisu identificirane sistemske nuspojave lijeka.
Date of first authorisation: 27/07/2010 Date of latest renewal: 23/03/2015 
Datum posljednje obnove odobrenja: 23. ožujka 2015.
• Hypersensitivity to the active substance or to any of the excipients as listed in section 6.1. 
• Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1.
The maximum treatment effect was observed at day 60 and the difference in the incidence of responders was statistically significant favouring OZURDEX compared with sham at all time points to day 90 following injection. 
Maksimalni učinak liječenja primijećen je 60. dana te je razlika u incidenciji bolesnika s odgovorom bila statistički značajna u korist lijeka OZURDEX u usporedbi s placebo postupkom u svim terminima do 90. dana nakon ubrizgavanja.
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit:risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached 
• prilikom svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik,
The most frequently reported adverse reactions in the study eye of patients who received OZURDEX were conjunctival haemorrhage (30.3%), increased intraocular pressure (25.0%) and cataract (11.8%). 
Najčešće prijavljene nuspojave u ispitivanom oku kod bolesnika koji su primili OZURDEX bile su krvarenje iz konjunktive (30,3%), povišeni očni tlak (25,0%) i katarakta (11,8%).
Pooled Studies 206207-010 and 
Objedinjena ispitivanja 206207-010 i
A total of 36% of OZURDEX treated patients discontinued study participation for any reason during the study compared with 57% of sham patients. 
Ukupno 36% bolesnika koji su primili OZURDEX isključeno je iz ispitivanja zbog bilo kojeg razloga, u usporedbi s 57% bolesnika iz placebo skupine.
Other than those patients contraindicated (see section 4.3) where OZURDEX should not be used, OZURDEX should be used with caution and only following a careful risk benefit assessment. 
Kod svih bolesnika, osim onih kod kojih se OZURDEX ne smije koristiti jer je to kontraindicirano (vidjeti dio 4.3), OZURDEX treba koristiti s oprezom i to samo nakon pažljive procjene koristi i rizika.
With the bevel of the needle up away from the sclera, advance the needle about 1 mm into the sclera then redirect toward the centre of the eye into the vitreous cavity until the silicone sleeve is against the conjunctiva. 
S kosim rubom igle okrenutim prema gore, gurnite iglu otprilike 1 mm u bjeloočnicu te je onda preusmjerite prema središtu oka u vitrealnu šupljinu dok silikonski omotač ne dodirne konjunktivu.
Patients of less than 45 years of age with macular oedema following Retinal Vein Occlusion or inflammation of the posterior segment of the eye presenting as non-infectious uveitis are more likely to experience increases in IOP. 
Kod bolesnika mlađih od 45 godina s makularnim edemom nakon okluzije mrežnične vene (RVO) ili upalom stražnjeg očnog segmenta koji se javlja kao neinfektivni uveitis postoji veća vjerojatnost da će se pojaviti porast očnog tlaka.
One sustained release sterile implantable rod shaped implant containing 700 micrograms of dexamethasone, located in the needle (stainless steel) of a disposable applicator. 
Jedan sterilni implantat produženog učinka u obliku štapića, koji sadrži 700 mikrograma deksametazona, a nalazi se u igli (od nehrđajućeg čelika) jednokratnog aplikatora.
In each of the phase III studies and the pooled analysis, mean retinal thickness was significantly less, and the mean reduction from baseline was significantly greater, with OZURDEX (-207.9 microns) compared to sham (-95.0 microns) at day 90 (p < 0.001, pooled data). 
U svakoj studiji faze III i u analizi objedinjenih podataka, prosječna debljina mrežnice bila je značajno manja, a prosječno smanjenje u odnosu na početne vrijednosti bilo je značajno veće s lijekom OZURDEX (-207,9 mikrona) u usporedbi s placebo postupkom (-95,0 mikrona) na 90. dan (p < 0,001, objedinjeni podaci).