PatientInformationLeaflet

TreatmentofDiabeticMacularOedemawithIntravitrealInjection

ofAnti-VEGFDrugsNameofConsultant:Address:Telephone:Emergencycontactdetails:

IntroductionYouhaveaneyeconditioncalledDiabeticMacularOedemaDME.TreatmentforDMEisbyinjectionofmedicineintothebackoftheeyeknownasanintravitrealinjection.Inordertoundergothistreatment,youhavetogiveconsentandtosignthehospitalconsentformwhereappropriate.Beforeyousigntheconsentform,itisimportantthatyoufullyunderstandthetreatmentyouareabouttohave,includingalternativetreatmentsandanyrisksorside-effects.

WhatisDiabeticMacularOedema?

DiabeticMacularOedemaisaleadingcauseofvisualimpairmentintheadultpopulation.Itoccursasadirectcomplicationofdiabeteswhichresultsindamagetothebloodvesselsinthecentralretinamacula.Asaresultthesebloodvesselsleakfluidintothemaculawhichleadstolossofvision.Withouttreatment,centralvisionlossmaybesevereandpermanent.

HowisDiabeticMacularOedematreated?

TreatmentofDMEcannotundothechangesalreadypresentintheeye,andthemaingoaloftreatmentisthereforetopreventfurtherlossofvision.Anti-VEGFdrugsaregivenbyinjectionintotheeyeandacttosloworstoptheleakagethatcauseDME.Althoughsomepatientshaveregainedvision,most

patients’visionwillstabilise.Anti-VEGFinjectionsmaynotrestorevisionthathasalreadybeenlost,anddonotalwayspreventfurtherlossofvisioncausedbythedisease.

Howisthetreatmentgiven?

Eyedropsareadministeredtodilatethepupilandsterilisetheeye.Oncethepupilisdilated,theactualproceduretakesaroundfifteenminutes.Youwillbebroughttotheprocedureroom,andaskedtolieinacomfortablepositiononatrolley.TheeyeisnumbedwithanaestheticdropsandwashedwithIodine.Theeyelidsareheldopenwithaninstrumentcalledaspeculum.Themedicationisinjectedintothevitreoushumour,whichisthejelly-likesubstanceinsidethebackoftheeye.Youmayexperienceslightdiscomfort,afeelingofpressure,orasharpfeelingontheeyeatthetimeofinjection.

Anti-VEGFinjectionsarerepeatedintoyoureyeonceamonthforfourtosixmonths,andthereafterasneededatregularintervals.Yourophthalmologisteyedoctorwilltellyouhowoftenyouwillreceivetheinjectionsandoverwhatlengthoftime.Itisoftennecessarytoattendforeyeexaminationsand/orinjectionsonamonthlybasisandperhapsforseveralyears.

Whatothertreatmentoptionsareavailable?

OtherformsoftreatmentareavailableforDiabeticMacularOedema.LaserPhotocoagulationcanbeusedtosealtheleakingbloodvesselsthatresultinDME.However,althoughlasercanreducetheriskoffurtherseverevisionloss,itdoesnotofferimprovementinvision.Someotherdrugsgivenbyinjectionaresometimesused.Theseoptionscanbeexplainedtoyoubyyoureyedoctor.

Youdonothavetoreceivetreatmentforyourcondition;however,withouttreatmentyourcentralvisionmaycontinuetoworsentothepointwheretreatmentmaynolongerhelp.

AlthoughDMErarelycausescompleteblindness,itcanreducethevisiontothepointwherereadinganddrivingarenotpossiblebecauseoflossofcentralvision.

Whataretherisksoftreatment?

Risksofintravitrealeyeinjections

Allsurgicalprocedureshaveaninherentrisk.However,thevastmajorityofpatientshavenoseriousproblem.Seriouscomplicationsoftheintravitreal

procedureincludeinfectionendophthalmitis,retinaldetachment,cataractformationandvitreoushaemorrhage.Anyoftheseseriouscomplicationsmayleadtodecreasedvisionand/orhaveapossibilityofcausingblindness,orevenlossoftheeye.Intheclinicaltrials,thesecomplicationsoccurredatarateof

lessthan0.1%ofinjections1inevery1,000cases.Otherseriousevents,suchasinflammationwithintheeyeandincreasepressureintheeye,occurredatarateoflessthan2%lessthan2outofevery100intheclinicaltrials.Additionalproceduresmaybeneededtotreatthesecomplications.

Whattoexpectafteraninjection

•Aftertheinjection,youmayhaveagrittyfeelingandtheeyemaylookbloodshotforafewdays.

•25%ofpatientswillexperienceabloodspotonthesurfaceoftheeyeatthesiteoftheinjection.Thiswillnotalteryourvision.

•Youmayseefloaters,whichwillbecomesmallerandwilldisappearoveronetotwoweeks.

•10%ofpatientsmayexperienceeyepainrelatingtothepre-injectionpreparationprocedureeyelidspeculum,eyedrops,eyewash.

•7%ofpatientswillexperiencevitreousfloatersorspotsinthevision.

•Lessthan10%willexperienceabrasionofthecornea,inflammationoftheeyeandvisualdisturbance.

•8%ofpatientswillexperienceariseinintraocularpressure

•7%ofpatientswilldevelopavitreousseparation/vitreousdetachment

Duringfollowupvisitsortelephonecalls,youwillbecheckedforpossibleside-effects,andtheresultwillbediscussedwithyou.

Complicationsofanti-VEGFdrugsinotherbodyparts

Thereisatheoreticalincreasedriskofexperiencingbloodclots(suchasmaycauseheartattackorstroke)afterintravitrealadministrationofanti-VEGFdrugsthateffectthegrowthofbloodvessels.However,alowincidenceoftheseeventswereseenintheclinicaltrials.Patientswithahistoryofstrokemaybeatgreaterriskforanotherstroke.Ifyouhaveahistoryofstroke,pleasediscussthiswithyoureyedoctor.Lowlevelsofanti-VEGFdrugscanreachyourbloodstreamafterinjectionintotheeye.

Coincidentalrisk

Wheneveramedicationisusedinalargecohortofpatients,coincidentalproblemsmayoccurthatcouldhavenorelationshiptothetreatment.Forexample,patientswithhighbloodpressureorsmokersarealreadyatincreasedriskforheartattacksandstrokes.Ifapatientbeingtreatedwithanti-VEGFdrugssuffersaheartattackorstroke,itmaybeasaresultofapatient’shighbloodpressureand/orsmoking,andnotnecessarilyduetothetreatment.

Yourconditionmaynotgetbetter,ormayevenbecomeworsedespitetheseinjections.

Thistreatmentmightnotbeeffectiveforyou.

Patientresponsibilities

Contacttheemergencynumberyouhavebeengivenorattendtheeyeaccidentandemergencydepartmentifyouexperienceanymajorproblemsafteraninjection.

Problemssuggestiveofaninfectioncaninclude:

•Eyepainasagainstthenormaldiscomfortaftertheprocedure

•Blurringornewdecreasedvisionasagainstaftertheprocedure

•Extremelightsensitivity

•Pusorotherdischargecomingfromtheeye

YOUcanhelppreventorreducetheseproblems:

1.Donotrubyoureye.

2.Donotgoswimmingforfivedaysaftereachinjection.

3.Washyourhandscarefullybeforeyouapplytheeyedrops.

4.Avoidstrenuousactivityandliftingheavyobjects.

5.Avoidgettingsoaporshampoointoyoureye.

6.Avoidwearingeyemake-upforuptooneweek.

7.Callyoureyedoctorophthalmologistrightawayifyounoticeanyoftheabovelistedsymptoms.

8.Keepallfollowupappointments.

Ifthereareanysignsofeye/eyelidinfectionpresentonthedayofyourplannedinjection,yourtreatmentmayneedtobere-bookedforanothertimetoallowcontrolofsuchinfection.

Pleaseinformyourdoctorifyouhaveastickyordischargingeye.

IrishCollegeofOphthalmologistsTheIrishCollegeofOphthalmologistsICOisthetrainingandprofessionalbodyforeyedoctorsinIreland.TheICOisdedicatedtopromotingandsettingthehigheststandardsofexcellenceandpatientcareinthepracticeofophthalmologyinIreland.Wedothisbyeducatingeyedoctorsintraining,providingon-goingeducationforeyedoctorsinpractice,givingaccuratemedicaladvicetothepublicandpolicyguidancetothegovernment.Forfurtherinformation,visitwww.eyedoctors.ie