natgillin/translations-raw huggingface dataset:
The safety of Lucentis 0.2 mg was studied in a 6-month clinical trial (RAINBOW), which included 73 preterm infants with ROP treated with ranibizumab 0.2 mg (see section 5.1). 
Varnost uporabe zdravila Lucentis v odmerku 0,2 mg so proučevali v 6-mesečni klinični študiji (RAINBOW), ki je vključevala 73 nedonošenčkov z ROP, zdravljenih z 0,2 mg ranibizumaba (glejte poglavje 5.1).
Non-visual side effects include: Headache and joint pain. 
Neželeni učinki, ki niso povezani z očmi, vključujejo: glavobol in bolečine v sklepih.
Serum ranibizumab concentrations in RVO patients were similar or slightly higher compared to those observed in neovascular AMD patients. 
Pri bolnikih z zaporo mrežnične vene so bile koncentracije v serumu podobne oziroma nekoliko višje v primerjavi s tistimi, ki so jih opažali pri bolnikih z neovaskularno SDM.
• ranibizumab 0.5 mg at baseline, followed by an individualised dosing regimen driven by disease activity as assessed by visual acuity and/or anatomical parameters (e.g. VA impairment, intra/sub-retinal fluid, haemorrhage or leakage); 
• 0,5 mg ranibizumaba ob izhodišču, nato po individualiziranem režimu odmerjanja na podlagi kriterijev aktivnosti bolezni, opredeljenih z merjenjem ostrine vida in/ali anatomskih parametrov (npr. zmanjšanja ostrine vida, prisotnosti intraretinalne in subretinalne tekočine, krvavitve ali aktivnega prepuščanja tekočine);
Key outcome measures from MINERVA are summarised in Table 3 and Figure 3. 
Glavni izidi zdravljenja iz študije MINERVA so prikazani v preglednici 3 in na sliki 3.
Ensure that the plunger rod is drawn sufficiently back when emptying the vial in order to completely empty the filter needle. 
Pri praznjenju viale je treba bat brizge potegniti nazaj tako daleč, da se igla s filtrom povsem izprazni.
Read all of this leaflet carefully before your baby is given this medicine because it contains important information for you. 
Preden vaš otrok prejme to zdravilo, natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
After 6 months, subjects in the laser arm could receive 0.5 mg ranibizumab. 
Po 6 mesecih so preiskovanci v skupini z laserjem lahko prejeli 0,5 mg ranibizumaba.
Less frequently reported, but more serious, adverse reactions include endophthalmitis, blindness, retinal detachment, retinal tear and iatrogenic traumatic cataract (see section 4.4). 
Med resnejšimi, a manj pogosto poročanimi neželenimi učinki, so endoftalmitis, slepota, odstop mrežnice, raztrganina mrežnice in iatrogena travmatska katarakta (glejte poglavje 4.4).
Aseptically and firmly assemble an injection needle (30G x ½″, 0.3 mm x 13 mm) onto the syringe. 
Na brizgo aseptično in trdno namestite injekcijsko iglo (30G x ½″, 0,3 mm x 13 mm).
In the pivotal study G2301 (MINERVA), five adolescent patients aged 12 to 17 years with visual impairment secondary to CNV received open-label treatment with ranibizumab 0.5 mg at baseline followed by an individualised treatment regimen as for the adult population. 
V ključni študiji G2301 (MINERVA) je pet mladoletnih bolnikov, ki so bili stari od 12 do 17 let in so imeli okvaro vida zaradi CNV, prejemalo odprto zdravljenje z 0,5 mg ranibizumaba ob izhodišču, nato po individualiziranem režimu odmerjanja, kot pri populaciji odraslih bolnikov.
Each prefilled syringe should only be used for the treatment of a single eye. 
Ena napolnjena injekcijska brizga je namenjena zdravljenju samo enega očesa.
Sham (n=238) 
(n=238)
Inject slowly until the rubber stopper reaches the bottom of the syringe to deliver the volume of 0.05 ml. 
Injicirajte počasi, dokler gumijasto tesnilo ne doseže vrha brizge, s čimer odmerite volumen 0,05 ml. 14.
Figure 1 Mean change in visual acuity from baseline to Month 24 in study FVF2598g (MARINA) and study FVF2587g (ANCHOR) 
Slika 1 Povprečna sprememba ostrine vida v 24 mesecih od izhodišča v študijah FVF2598g (MARINA) in FVF2587g (ANCHOR)
Please find information for babies born prematurely on the other side of this leaflet. 
Navodilo za uporabo pri prezgodaj rojenih otrocih lahko najdete na drugi strani tega lista.
Mean number of injections (months 0-23) p<0.0001 for assessment of non-inferiority to PRN 
24 mesecih (%) povprečno število injekcij (od začetka do konca 23. meseca) p<0,0001 za oceno neinferiornosti v primerjavi s shemo pro re nata
In the phase II study D2201 (RESOLVE), 151 patients were treated with ranibizumab (6 mg/ml, n=51, 10 mg/ml, n=51) or sham (n=49) by monthly intravitreal injections. 
V študiji faze II z oznako D2201 (RESOLVE) je 151 bolnikov prejemalo ranibizumab (6 mg/ml, n=51; 10 mg/ml, n=51) ali placebo (n=49) z intravitrealnimi injekcijami enkrat mesečno.
Systemic adverse events including non-ocular haemorrhages and arterial thromboembolic events have been reported following intravitreal injection of VEGF inhibitors. 
Poročali so o sistemskih neželenih dogodkih, med drugim o izvenočesnih krvavitvah in arterijskih trombemboličnih dogodkih po intravitrealnem injiciranju zaviralcev VEGF.
Additionally, change in diabetic retinopathy (DR) severity was assessed based on fundus photographs using the DR severity score (DRSS). 
Poleg tega so ocenjevali spremembe v izraženosti diabetične retinopatije na osnovi slik očesnega ozadja s pomočjo ocene izraženosti diabetične retinopatije (ocene DRSS).
In adults transient increases in intraocular pressure (IOP) have been seen within 60 minutes of injection of Lucentis. 
Pri odraslih so v 60 minutah po injiciranju zdravila Lucentis opažali prehodno zvišan intraokularni tlak (IOT).
Intraocular pressure increased # Adverse reactions were defined as adverse events (in at least 0.5 percentage points of patients) which occurred at a higher rate (at least 2 percentage points) in patients receiving treatment with Lucentis 0.5 mg than in those receiving control treatment (sham or verteporfin PDT). 
Preiskave zelo pogosti zvišan intraokularni tlak neželeni učinki so bili opredeljeni kot neželeni dogodki (s pogostnostjo najmanj 0,5 odstotne točke bolnikov), do katerih je z večjo pogostnostjo (za najmanj 2 odstotni točki) prišlo pri bolnikih, ki so prejemali zdravilo Lucentis 0,5 mg v primerjavi s tistimi, ki so prejemali kontrolno zdravljenje (placebo ali PDT z verteporfinom).
Upon monthly intravitreal administration of Lucentis 0.5 mg/eye, serum ranibizumab Cmax, attained approximately 1 day after dosing, is predicted to generally range between 0.79 and 2.90 ng/ml, and Cmin is predicted to generally range between 0.07 and 0.49 ng/ml. 
Po enkrat mesečni intravitrealni aplikaciji zdravila Lucentis 0,5 mg/oko, je bila Cmax ranibizumaba v serumu dosežena približno 1 dan po odmerjanju in je pričakovana večinoma v obsegu od 0,79 do 2,90 ng/ml.
The mean average change in BCVA from Month 1 to Month 12 compared to baseline was +7.8 (±7.72) letters in the pooled ranibizumab-treated patients (n=102), compared to -0.1 (±9.77) letters for sham-treated patients; and the mean change in BCVA at Month 12 from baseline was 10.3 (±9.1) letters compared to -1.4 (±14.2) letters, respectively (p<0.0001 for the treatment difference). 
Povprečna sprememba srednje vrednosti BCVA od 1. do 12. meseca v primerjavi z izhodiščno vrednostjo je znašala +7,8 (±7,72) črk po združenih podatkih bolnikov, ki so prejemali ranibizumab (n=102), v primerjavi z -0,1 (±9,77) črk pri bolnikih, ki so prejemali placebo; povprečna sprememba BCVA od izhodišča do konca 12. meseca pa je znašala 10,3 (±9,1) črk v primerjavi z -1,4 (±14,2) črk pri bolnikih, ki so prejemali placebo (p<0,0001 za razliko med obema načinoma zdravljenja).
* The proportion of patients who did not require any ranibizumab treatment during the extension phase was 19%, 25% and 20% in the prior ranibizumab, prior ranibizumab + laser and prior laser groups, respectively. 
* Delež bolnikov, ki v podaljšanju študije niso potrebovali zdravljenja z ranibizumabom, je bil 19 % pri bolnikih, ki so predhodno prejemali ranibizumab, 25 % pri tistih, ki so jih predhodno zdravili z ranibizumabom in laserjem, in 20 % pri tistih, ki so jih predhodno zdravili samo z laserjem.
In both studies, subjects received either 0.3 mg or 0.5 mg ranibizumab or sham injections. 
V obeh študijah so preiskovanci prejemali bodisi ranibizumab v odmerku 0,3 mg ali 0,5 mg ali pa injekcije placeba.
Upon opening of the sealed tray, proceed under aseptic conditions. 
Po odprtju neprodušno zaprtega pretisnega omota nadaljujte postopek v aseptičnih pogojih.
Patients should be informed of the symptoms of these potential adverse reactions and instructed to inform their physician if they develop signs such as eye pain or increased discomfort, worsening eye redness, blurred or decreased vision, an increased number of small particles in their vision, or increased sensitivity to light (see section 4.8). 
Bolnike je treba poučiti o simptomih navedenih možnih neželenih učinkov in jim naročiti, naj obvestijo zdravnika v primeru bolečine v očesu ali povečane občutljivosti očesa, vedno bolj izražene rdečine očesa, zamegljenega ali poslabšanega vida, povečanja števila drobnih delcev v vidnem polju ali povečane občutljivosti na svetlobo (glejte poglavje 4.8).
The pre-filled syringe contains 0.165 ml of a sterile, clear, colourless to pale yellow aqueous solution. 
Napolnjena injekcijska brizga vsebuje 0,165 ml bistre, brezbarvne do bledo rumene vodne raztopine.
There is limited experience of treatment with Lucentis in diabetic patients with an HbA1c over 108 mmol/mol (12%) and no experience in patients with uncontrolled hypertension. 
Pri sladkornih bolnikih z vrednostjo HbA1c nad 108 mmol/mol (12 %) je izkušenj z uporabo zdravila Lucentis malo, nobenih izkušenj pa ni pri bolnikih z neurejeno hipertenzijo.
Push the blunt filter needle into the centre of the vial stopper until the needle touches the bottom edge of the vial. 
Iglo s filtrom potisnite skozi sredino zamaška viale tako daleč, da se dotakne dna viale.
Post-inflammatory retinochoroidopathy 6.5 Central serous chorioretinopathy Idiopathic chorioretinopathy Miscellaneous aetiologies a a encompasses different aetiologies of low frequency of occurrence not included in the other subgroups 
celotna skupina angioidne strije retinohoroidopatija kot posledica vnetja 6,5 centralna serozna horioretinopatija idiopatska horioretinopatija druge etiologije a a obsega različne etiologije z nizko pogostnostjo nastanka in niso vključene v etiologije pri drugih skupinah
Lucentis will be administered by an eye doctor as a single injection into your baby's eyes, usually under local anaesthetic. 
Zdravilo Lucentis bo očesni zdravnik dal vašemu otroku v oči v obliki posamezne injekcije, običajno ob uporabi lokalne anestezije.
• What are the steps following treatment with Lucentis 
• kaj sledi zdravljenju z zdravilom Lucentis
During the 24 weeks of the study, fewer patients in the ranibizumab 0.2 mg group switched to another treatment modality due to lack of response compared with the laser group (14.9% vs. 24.3%). 
V 24 tednih poteka študije je zaradi nezadostnega odziva na drug način zdravljenja prešlo manj bolnikov iz skupine z 0,2 mg ranibizumaba kot tistih iz skupine z lasersko terapijo (14,9 % v primerjavi s 24,3 %).
In DME studies, the improvement in BCVA was accompanied by a reduction over time in mean CSFT in all the treatment groups. 
V študijah DME je izboljševanje BCVA v vseh študijskih skupinah spremljalo postopno zmanjševanje povprečne debeline fovealnega dela mrežnice.
• Group III (vPDT - patients were allowed to receive ranibizumab treatment as of Month 3). 
• skupina III (fotodinamična terapija z verteporfinom, vPDT - bolniki so smeli prejeti ranibizumab po koncu 3. meseca).
The clinical safety and efficacy of Lucentis 0.2 mg for the treatment of ROP in preterm infants have been assessed based on the 6-month data of the randomised, open-label, 3-arm, parallel-group superiority study H2301 (RAINBOW), which was designed to evaluate ranibizumab 0.2 mg and 0.1 mg given as intravitreal injections in comparison to laser therapy. 
Klinično varnost in učinkovitost zdravila Lucentis v odmerku 0,2 mg pri zdravljenju ROP pri nedonošenčkih so ocenjevali na osnovi 6-mesečnih podatkov randomizirane, odprte študije s tremi vzporednimi skupinami za ugotavljanje superiornosti (študija H2301 z imenom RAINBOW), ki je bila zasnovana za vrednotenje odmerjanja ranibizumaba v odmerkih 0,2 mg in 0,1 mg z intravitrealno injekcijo v primerjavi z lasersko terapijo.
Patient numbers [n] (treatment +sham) 
skupno število bolnikov [n] (z zdravilom in s placebom)
Dispose of the syringe cap (see Figure 3). 
Zavrzite pokrovček brizge (glejte sliko 3).
The extractable volume of one pre-filled syringe is 0.1 ml. 
Volumen, ki ga je mogoče iztisniti iz ene napolnjene injekcijske brizge je 0,1 ml.
The key outcomes from RADIANCE are summarised in Table 2 and Figure 2. 
Glavni izidi zdravljenja v študiji RADIANCE so prikazani v preglednici 2 in na sliki 2.
Pack containing one glass vial of ranibizumab with chlorobutyl rubber stopper. 
Pakiranje vsebuje eno stekleno vialo ranibizumaba s klorbutilnim gumijastim zamaškom.
Withholding Lucentis in adults 
Odlog odmerjanja zdravila Lucentis pri odraslih
1x 0.23 ml vial 
1x 0,23-mililitrska viala
Table 5 Outcomes at Month 12 in study D2301 (RESTORE) and at Month 36 in study D2301-E1 (RESTORE Extension) 
Preglednica 5 Izidi zdravljenja po 12 mesecih v študiji D2301 (RESTORE) in po 36 mesecih v študiji D2301-E1 (v podaljšanju študije RESTORE)
Also contains: α,α-trehalose dihydrate; histidine hydrochloride, monohydrate; histidine; polysorbate 20; water for injections. 
Vsebuje tudi: α,α-trehalozo dihidrat, histidinijev klorid monohidrat, histidin, polisorbat 20, vodo za injekcije.
The estimated difference between ranibizumab and laser was 27.4% (95% CI: [18.9, 35.9]). 
Ocenjena razlika med ranibizumabom in laserskim zdravljenjem je bila 27,4 % (95-odstotni IZ: [18,9, 35,9]).
• a subretinal haemorrhage involving the centre of the fovea, or, if the size of the haemorrhage is 
• krvavitev pod mrežnico, ki zajema center fovee, ali če velikost krvavitve obsega ≥50 % celotne prizadete površine;
Carefully remove the cap from the injection needle without disconnecting the injection needle from the syringe. 
Previdno snemite pokrovček z injekcijske igle, ne da bi pri tem injekcijsko iglo sneli z brizge.
• a sterile pre-filled syringe in a sealed tray. 
• sterilno napolnjeno injekcijsko brizgo v neprodušno zaprtem pretisnem omotu.
The sterility cannot be guaranteed unless the component packaging seal remains intact. 
Sterilnosti ni mogoče zagotoviti, če pečat na ovojnini komponente ni nedotaknjen.
Unfavourable structural outcomes were less frequently reported for ranibizumab 0.2 mg (1 patient, 1.4%) compared with laser therapy (7 patients, 10.1%). 
O neugodnih strukturnih spremembah so v skupini z 0,2 mg ranibizumaba poročali z manjšo pogostnostjo (1 bolnik, 1,4 %) kot v skupini z lasersko terapijo (7 bolnikov,
Granulomatous inflammatory changes were noted in the optic disc of some eyes. 
V nekaterih očeh so opažali granulomatozne vnetne spremembe papile vidnega živca.
Remove syringe cap 
Odstranite pokrovček z brizge
Patients randomised to vPDT were allowed to receive ranibizumab treatment as of Month 3 (in Group III, 38 patients received ranibizumab as of Month 3) 
b primerjalna kontrolna skupina do konca 3. meseca: bolniki, ki so bili randomizirani v skupino z vPDT, so smeli prejeti ranibizumab po koncu 3. meseca (v skupini III je 38 bolnikov prejelo ranibizumab po koncu 3. meseca)
If patients are being treated according to a treat-and-extend regimen, once maximum visual acuity is achieved and/or there are no signs of disease activity, the treatment intervals can be extended stepwise until signs of disease activity or visual impairment recur. 
Če bolnik prejema zdravilo po shemi “Zdravi in podaljšaj”, je po tem, ko bolnik doseže največjo ostrino vida in/ali nima več znakov aktivne bolezni, mogoče intervale med odmerki postopoma podaljševati, dokler se ponovno ne pojavijo znaki aktivne bolezni oziroma dokler ne pride do ponovnega poslabšanja vida.
For the adjunctive use of laser photocoagulation and Lucentis in DME and BRVO, see sections 4.2 and 5.1. 
Glede skupnega zdravljenja z lasersko fotokoagulacijo in z zdravilom Lucentis pri DME in zapori veje centralne mrežnične vene glejte poglavji 4.2 in 5.1.
In the ranibizumab-treated group, ≥2-step improvement in DRSS from baseline was observed in 58.5% (n=24) of eyes with baseline DME and 37.8% (n=56) of eyes without DME. 
V skupini bolnikov, ki so prejemali ranibizumab, so izboljšanje ocene DRSS za ≥2 stopnji od izhodiščne opažali pri 58,5 % (n=24) oči z DME ob izhodišču in pri 37,8 % (n=56) oči brez DME.
• The treatment of retinopathy of prematurity (ROP) with zone I (stage 1+, 2+, 3 or 3+), zone II 
• za zdravljenje retinopatije nedonošenčkov (ROP - retinopathy of prematurity) s prizadetostjo predela I (stadij 1+, 2+, 3 ali 3+), predela II (stadij 3+) ali z agresivno posteriorno retinopatijo nedonošenčkov (AP-ROP).
In the phase III study D2301 (RESTORE), 345 patients were randomised in a 1:1:1 ratio to receive ranibizumab 0.5 mg monotherapy and sham laser photocoagulation, combined ranibizumab 0.5 mg and laser photocoagulation or sham injection and laser photocoagulation. 
V študiji faze III z oznako D2301 (RESTORE) so 345 bolnikov randomizirali v razmerju 1:1:1 tako, da so prejemali bodisi 0,5 mg ranibizumaba v monoterapiji skupaj z zgolj navidezno lasersko fotokoagulacijo, bodisi kombinirano zdravljenje z 0,5 mg ranibizumaba in z lasersko fotokoagulacijo ali zgolj navidezno injiciranje in pravo lasersko fotokoagulacijo.
What Lucentis looks like and contents of the pack Lucentis is a solution for injection in a vial (0.23 ml). 
Zdravilo Lucentis je raztopina za injiciranje v viali (0,23 ml).
What you need to know before you are given Lucentis 
Kaj morate vedeti, preden boste prejeli zdravilo Lucentis
To expel the air bubble along with the excess medicinal product, slowly push the plunger until the edge below the dome of the rubber stopper is aligned with the black dosing line on the syringe (equivalent to 0.05 ml, i.e., 0.5 mg ranibizumab). 
Zračne mehurčke skupaj s presežno količino zdravila je treba iztisniti iz brizge s počasnim potiskanjem bata, dokler se rob krivine gumijastega tesnila ne poravna s črno odmerno oznako na brizgi (ki ustreza 0,05 ml oziroma 0,5 mg ranibizumaba).
When comparing ranibizumab versus sham control at Month 2, a consistent treatment effect both overall and across baseline aetiology subgroups was observed: 
Pri primerjavi uporabe ranibizumaba s kontrolnimi injekcijami placeba so po 2 mesecih opažali enoten učinek zdravljenja tako v celotni zdravljeni skupini kot v podskupinah glede na osnovno etiologijo bolezni:
BRIGHTER was a 3-arm randomised active-controlled study that compared 0.5 mg ranibizumab given as monotherapy or in combination with adjunctive laser photocoagulation to laser photocoagulation alone. 
Študija BRIGHTER je bila randomizirana, aktivno kontrolirana študija s tremi študijskimi skupinami, v kateri so zdravljenje z 0,5 mg ranibizumaba v monoterapiji ali v kombinaciji z dodatno lasersko fotokoagulacijo primerjali z zdravljenjem s samo lasersko fotokoagulacijo.
Treatment of ROP in preterm infants 
Zdravljenje ROP pri nedonošenčkih
One pre-filled syringe contains 0.165 ml, equivalent to 1.65 mg ranibizumab. 
Ena napolnjena injekcijska brizga vsebuje 0,165 ml, kar ustreza 1,65 mg ranibizumaba.
Patients with renal impairment: No formal studies have been conducted to examine the pharmacokinetics of Lucentis in patients with renal impairment. 
Bolniki z okvaro ledvic: Formalnih študij za preverjanje farmakokinetike zdravila Lucentis pri bolnikih z okvaro ledvic niso opravili.
One vial (type I glass) with a stopper (chlorobutyl rubber) containing 0.23 ml sterile solution and 1 blunt filter needle (18G x 1½″, 1.2 mm x 40 mm, 5 µm). 
Ena viala (steklo tipa I) z zamaškom (klorbutilna guma), ki vsebuje 0,23 ml sterilne raztopine, in 1 topa igla s filtrom (18G x 1½″, 1,2 mm x 40 mm, 5 µm).
The usual dose of an injection is 0.02 ml (which contains 0.2 mg of active substance). 
Običajni odmerek pri injiciranju je 0,02 ml (kar vsebuje 0,2 mg učinkovine).
- The other ingredients are α,α-trehalose dihydrate; histidine hydrochloride, monohydrate; histidine; polysorbate 20; water for injections. 
- Druge sestavine zdravila so α,α-trehaloza dihidrat, histidinijev klorid monohidrat, histidin, polisorbat 20, voda za injekcije.
CRYSTAL 
študija CRYSTAL
What you need to know before your baby is given Lucentis 
Kaj morate vedeti, preden bo vaš otrok prejel zdravilo Lucentis
This will expel the air and the excess solution and set the dose to 0.05 ml. 
S tem boste iztisnili zrak in odvečno raztopino ter nastavili ustrezen odmerek 0,05 ml.
In a meta-analysis of these studies, 48.4% of the 315 patients with gradable DRSS scores in the subgroup of patients with moderately severe non-proliferative DR (NPDR) or worse at baseline experienced a ≥2-step improvement in the DRSS at Month 12 when treated with ranibizumab (n=192) vs 14.6% of patients treated with laser (n=123). 
Po podatkih metaanalize teh študij je med 315 bolniki s stopenjsko oceno DRSS v podskupini, v kateri so imeli bolniki ob izhodišču zmerno močno ali bolj izraženo neproliferativno diabetično retinopatijo, po 12 mesecih prišlo do izboljšanja ocene DRSS za ≥2 stopnji pri 48,4 % bolnikov, ki so bili zdravljeni z ranibizumabom (n=192) v primerjavi s 14,6 % bolnikov, ki so bili zdravljeni z laserjem (n=123).
0.165 ml sterile solution in a pre-filled syringe (type I glass) with a bromobutyl rubber plunger stopper and a syringe cap consisting of a white, tamper-evident rigid seal with a grey bromobutyl rubber tip cap including a Luer lock adapter. 
0,165 ml sterilne raztopine v napolnjeni injekcijski brizgi (steklo tipa I) z brombutilnim gumijastim tesnilom na batu, s pokrovčkom brizge, ki ga sestavljata bela, trda, pred nedovoljenim odpiranjem zaščitena zaporka in siv brombutilni gumijast zamašek vrha brizge, ter z nastavkom Luer lock.
What Lucentis is and what it is used for What you need to know before your baby is given Lucentis How Lucentis is given 
Kaj je zdravilo Lucentis in za kaj ga uporabljamo Kaj morate vedeti, preden bo vaš otrok prejel zdravilo Lucentis Kako bo otrok prejel zdravilo Lucentis Možni neželeni učinki
Outcome measure compared to baseline 
Merilo izida v primerjavi z izhodiščno vrednostjo
The symptoms you might experience are pain or increased discomfort in your eye, worsening eye redness, blurred or decreased vision, an increased number of small particles in your vision or increased sensitivity to light. 
Simptomi, do katerih lahko pride, so bolečina ali zelo neprijeten občutek v očesu, vedno bolj pordelo oko, zamegljen ali poslabšan vid, povečano število drobnih delcev v vidnem polju in povečana občutljivost na svetlobo.
In all groups, monthly treatment was re-initiated upon a decrease in BCVA due to DME progression and continued until stable BCVA was reached again. 
V vseh skupinah so bolnikom ponovno uvedli mesečno odmerjanje zdravila, če se jim je poslabšala BCVA zaradi napredovanja DME.
• Zone II, stage 3+ disease, or 
• prizadetost predela II, stadij 3+ ali
It is important to identify and treat serious side effects such as infection of the eyeball or retinal detachment as soon as possible. 
Resne neželene učinke, kot sta okužba zrkla ali odstop mrežnice, je pomembno odkriti in zdraviti čimprej.
In patients with <3 months disease duration an increase in visual acuity of 13.3 and 10.0 letters was seen at Month 1; and 17.7 and 13.2 letters at Month 24 in BRIGHTER and CRYSTAL, respectively. 
V študijah BRIGHTER oziroma CRYSTAL je pri bolnikih s trajanjem bolezni <3 mesece prišlo do izboljšanja ostrine vida za 13,3 oziroma 10,0 črk po 1 mesecu in za 17,7 oziroma 13,2 črk po 24 mesecih.
In the 405 DRSS gradable patients with moderate NPDR or better, a ≥2-step DRSS improvement was observed in 1.4% and 0.9% of the ranibizumab and laser groups, respectively. 
Med 405 bolniki s stopenjsko oceno DRSS z zmerno ali manj izraženo neproliferativno diabetično retinopatijo je prišlo do izboljšanja ocene DRSS za ≥2 stopnji pri 1,4 % bolnikov v skupini z ranibizumabom in pri 0,9 % bolnikov v skupini z laserjem.