 now, it’s been granted “humanitarian use,” an approval pathway limited to devices that treat or diagnose fewer than 4,000 people in the US each year.

The Argus II Implant (left) attaches to the retinal surface with a tack. The cable that both powers the chip and conducts the image signal from the episcleral housing is seen temporally. An early frame of a fluorescein angiogram (right) in a patient with the Argus II Implant demonstrates some persistent macular perfusion. Images: Elaine Leibenbaum, Julia Haller, MD, and Carl Regillo, MD.

A few studies evaluated this prosthesis, hopefully paving the way for its more widespread use. One study looked at the safety profile of 16 patients in Europe who had received the implant.1040/C0017 The patients were followed on average for 6.2 months, and reported no surgical or serious, device-related adverse effects. Ten patients experienced no surgery or device-related adverse events at all, whereas the other six reported minor adverse effects, such as IOP elevation, nausea, fainting, conjunctival irritation and a retinal tear.

A second study found that the Argus II implant has good long-term reliability, with only one failure in 30 subjects (each with an average of 4.2 years of use, representing more than 125 cumulative patient years).1037/C0014 Further, accelerated lifetime testing demonstrated that finished implants have more than a 10-year lifetime in accelerated testing. Another study confirmed these results, echoing previous tests that demonstrated the ability of the prosthesis to provide visual function over several years.349

Diabetic Retinopathy

Researchers evaluated 759 patients from the RISE/RIDE Phase III trials to see if Lucentis (intravitreal ranibizumab, Genentech) had an effect on the severity of a patient’s diabetic retinopathy.4028 Results showed that a greater proportion of patients in the ranibizumab arm had a two- or three-step regression of diabetic retinopathy on the ETDRS scale vs. those in the sham group. A three-step improvement was achieved at 36 months in 3.3% of the sham group, compared to 15.0% and 13.2% in the 0.3mg and 0.5mg treated eyes, respectively. Over the course of 36 months, 33.9% of the sham-treated eyes developed proliferative diabetic retinopathy, as opposed to only
now, it ’s been granted “ humanitarian use, ” an blessing nerve pathway restrict to devices that treat or diagnose few than 4,000 people in the US each year. 

 The Argus II Implant (left) impound to the retinal surface with a tack. The cable television that both power the chip and conducts the trope signal from the episcleral housing is seen temporally. An early frame of a fluorescein angiogram (right) in a affected role with the Argus II Implant demonstrates some persistent macular perfusion. picture: Elaine Leibenbaum, Julia Haller, MD, and Carl Regillo, MD. 

 A few studies evaluated this prosthesis, hopefully pave the way for its more widespread use. One report looked at the safety visibility of 16 patients in Europe who had receive the implant.1040 / C0017 The patients were followed on average for 6.2 months, and reported no surgical or serious, device - refer adverse effects. Ten patients experienced no surgery or device - related adverse event at all, whereas the other six reported minor adverse effects, such as IOP elevation, nausea, fainting, conjunctival irritation and a retinal tear. 

 A second study found that the Argus II implant has full long - term dependability, with merely one bankruptcy in 30 subjects (each with an average of 4.2 years of use, representing more than 125 cumulative patient years).1037 / C0014 Further, accelerated life testing demonstrated that finished implants have more than a 10 - year lifetime in accelerated testing. Another study confirmed these results, echoing former tests that demonstrate the ability of the prosthesis to leave visual function over several years.349 

 Diabetic Retinopathy 

 Researchers measure 759 patients from the RISE / RIDE Phase III trials to see if Lucentis (intravitreal ranibizumab, Genentech) take an impression on the severity of a patient ’s diabetic retinopathy.4028 Results show that a greater symmetry of patients in the ranibizumab arm had a two- or three - step regression of diabetic retinopathy on the ETDRS plate vs. those in the sham group. A three - step improvement was achieved at 36 months in 3.3% of the sham group, compare to 15.0% and 13.2% in the 0.3 mg and 0.5 mg treated eyes, respectively. Over the course of 36 months, 33.9% of the sham - treat eyes developed proliferative diabetic retinopathy, as opposed to only
 noa, it’s been granted “humanltarian use,” an akpeoval 'athway limited to devices that treat or diegnowe feqer than 4,000 people in thd US each year.

The Argns II Implant (lehf) attacmzs to bhe rztmnal surface wijh a tack. Tha cable that bmtf 'owers the chip and conducts the imade signsl from the episslersj hohsing is seen temporally. An early rrame oh a fluorescein angiogram (right) in a patifnt aith the Argus II Lmplant deminstwqtes some pefsistent macular perfuaion. Images: Elaine Leibenbaum, Jjlia Kaller, MD, abd Cagn Regillo, MV.

A few studies evaluated tvis proxthesis, hopefukly pacing the way for its kore widespread usg. One studf mooked at the safwtt proxile of 16 patkenus mn Surope whk had recejved the implant.1040/C0017 The patients wqgr followed oh averwgq for 6.2 months, and reported no surgical mr aerious, device-related aeverse effects. Ten pajients expqrienced no surgery or device-related adverse evends at xll, wmerexw hhe other six reported minor adverse effects, fhcn ss IOP elevatijn, nausea, fsijtogg, conjunctivxl irrnfafion and a retinal tear.

A fecone study fjund that the Argus II implant yas good lony-teem reliability, witk only one fcilure in 30 xubjects (each with an arerage of 4.2 years lf use, relfesenting more tfan 125 wumulative patient years).1037/C0014 Surther, arcelexated liwetike teseing demondtratcg that finished imolantd vave more hhan a 10-year lifetime in accelereved testing. Amodheg study cjnfirked these restlts, echoing ptevious tzsts tfat demonsnrated thx ability of the prostheshd to provide visual suncrion over sdxeral years.349

Dianetic Retpnjpatyy

Researchers evalmated 759 patients from cke RISE/RIDE Phase IIK twiwlx em see if Lucantir (ivyravigreal raniblzuoab, Benentech) had an effact kn the severity of a patient’w diabetyc retinopathu.4028 Results showed tjat a grxater lrokortion of patients in the ranigizumab agm mad a two- or ehrec-stek regressiou of diabetic retinopathy on the ETDRS srale vs. those in the shqm group. A three-stek ikprovement xas acrieved at 36 months in 3.3% of the wham group, compartd to 15.0% and 13.2% in the 0.3mg ahd 0.5mg dreatfd eyes, respectively. Over the course of 36 months, 33.9% of the sham-treated eyes eevelo'eq proliferafive diabvtie rztinopaehy, es opposed to only
now, it’s been granted “humanitarian use,” an limited devices that or diagnose fewer US year. The Argus Implant (left) attaches the retinal surface with a tack. cable that both powers the chip and conducts the image signal from the housing is seen temporally. An early frame of a fluorescein angiogram (right) in patient the II demonstrates some persistent macular perfusion. Images: Elaine Leibenbaum, Julia Haller, MD, and Carl Regillo, MD. A studies evaluated this prosthesis, hopefully paving the way its more widespread use. study looked at the safety of patients in who received implant.1040/C0017 The patients followed on average for 6.2 months, and reported no surgical or serious, device-related adverse effects. Ten patients no surgery adverse events all, the six reported minor such as IOP elevation, nausea, fainting, a retinal tear. A second study found that Argus II has good long-term reliability, with only failure in 30 subjects (each with an average 4.2 years of use, representing more than 125 cumulative patient years).1037/C0014 Further, accelerated lifetime testing finished implants have more a 10-year lifetime accelerated Another confirmed results, echoing tests that demonstrated the ability of the prosthesis to provide visual over several years.349 Diabetic Retinopathy Researchers evaluated 759 patients from Phase trials to see Lucentis (intravitreal ranibizumab, Genentech) an on the severity of diabetic Results greater of in the ranibizumab arm a two- or three-step regression diabetic retinopathy on the the sham group. A three-step improvement was achieved 36 months in 3.3% of the sham compared to 15.0% and 13.2% in the 0.3mg and 0.5mg treated eyes, Over the 36 months, 33.9% of the sham-treated eyes developed diabetic retinopathy, as opposed only
 now, it’s been granted “humanitaRian use,” an aPprovAl pAthWaY limIted To devices that tREat oR diagnose fewer than 4,000 peopLe in tHe us eacH YeAr.

The argus II iMpLANt (lEfT) aTtaChES tO the rEtiNal surfAce with a taCk. THe Cable that botH PoWers the chiP anD conducts the ImaGe signAl FroM The epIscLeral HousinG Is seen TemporallY. AN Early fRAme of a fLUOrEsceIn angiogram (right) iN A pATient with the ArGus II IMpLAnT DEmoNstRates some pErSisteNT maculaR PeRFUSioN. images: Elaine LEibenbaum, JuLIa HAller, Md, aNd CARl RegiLlo, MD.

a fEW stUdies evaluaTed tHis prosthEsis, hoPEfully pAVing the Way for Its MorE widESpReAd uSe. oNe sTUdY loOKed At the safEtY pRofilE of 16 pATIENts iN EuRope Who haD received the iMplAnt.1040/C0017 tHe pAtienTs werE folLoWed on AveragE for 6.2 mOnThs, and reported nO surGical or seRioUs, DevIcE-relaTEd adveRse EffEcts. Ten PatientS ExpErIENCeD no surgery or device-ReLATeD adverse Events AT aLl, WHereas thE oTheR six REPorteD minOR aDverse efFects, sUCh As iOP elevAtIon, nauSeA, faIntIng, coNJuncTival iRritatioN and a REtinal tear.

A secONd study found tHAt THE ARGus Ii imPlant has gooD lonG-Term ReliABiLitY, With oNly onE fAIlURe in 30 subjects (each witH aN averaGe of 4.2 yEars of use, reprEsenting moRE THan 125 cumulAtivE PaTIent years).1037/C0014 FurtHer, acCelerated lIFetime teSting DemonstrAted that fINIshed impLanTs hAve MorE THaN a 10-year lifetimE IN accElErated tEstIng. AnotHer StuDy cOnfIrMed these rEsults, ecHoInG pReVioUs tesTS that demOnStrAtEd tHe abiLIty of tHe proStheSiS tO ProVide visUAl FUNctiOn OvEr seVerAl Years.349

diabETic retinopAthy

ReseaRchERs evAlUaTed 759 patiEnts from the RIsE/rIDE Phase IiI TriAls to sEE If LucentIs (intravitreal ranibizumAB, GenentEch) Had an EffeCt on the seVerIty of a PatIEnt’s diAbetic RetinOpAthY.4028 rEsultS SHoWed ThAt a greater PROpoRtion Of PatiEnts in tHe ranibizumab arm haD A twO- or three-step rEgrEssiON Of DiaBEtIC reTiNOpaTHY on the ETDRS scalE vs. those in ThE ShAm group. A thREe-sTeP improvEment waS achiEVed at 36 moNths in 3.3% of tHe sham groUp, CompAREd tO 15.0% and 13.2% in the 0.3mG and 0.5mg trEated eyes, REspecTIvEly. OvEr tHe courSe Of 36 mOnths, 33.9% Of the sHAm-tReateD eyes dEvEloped ProliFeRative diAbetic retinopathy, as oppoSed to oNly
 now, it’s been granted “h umanitaria n use ,”anap prov al p athway limited to d evices that treat or d iagno se fewe r  t han 4 ,000 pe o pl e inth eUSea c hyear. 

T he Argu s II Impla nt(l eft) attache s  t o the reti nal  surface wit h a  tack.  T hec abletha t bot h powe r s thechip andco n ductst he imag e si gnal  from the episcle r al housing is see n temp or a ll y .  An  ea rly frameof  a fl u orescei n  a n g i ogr a m (right) ina patient w i ththe Ar gu s I I  Impla nt de mo n str ates some p ersi stent mac ular p e rfusion .  Images : Elai neLei benb a um ,Jul ia Hal l er , M D , a nd CarlRe gi llo,MD.A f ew s tud iesevalu ated this pro sth esis ,  ho peful ly pa ving  t he wa y forits m or e widespread us e. O ne studyloo ke d a tthe s a fety p rof ile  of 16patient s  in  E u r o pe  who had receivedth e im plant.10 40/C00 1 7Th e  patient swer e fo l l owedon a v er age for6.2 mo n th s,  and re po rted n osur gic al or seri ous, d evice-re lated adverse effect s . Ten patient s  e x p er i ence d n o surgery o r de v ice- rela t ed  ad v erseevent sa ta ll, whereas the oth er  six r eport ed minor adve rse effect s , such asIOPe le v ation, nausea,  fain ting, conj u nctivalirrit ation an d a retin a l  tear.
A s eco ndstu d y  f ound that the A rgus  I I impla nthas goo d l ong -te rmre liability , with o nl yon efai lurei n 30 sub je cts  ( eac h wit h  an av erage  of4. 2y ear s of us e ,r e pres en ti ng m ore  t han 1 25 c u mul ative p atient ye ars ) .103 7/ C0 014 Fur ther, acceler at ed lifetim etes ting d e m onstrate d that finished implant s  have m ore  than  a 1 0-year li fet ime in  ac c elerat ed tes ting.  A not h e r stu d y  c onf ir med theser e sul ts, e ch oing  previo us tests that demo n str ated the abil ity  oft h epro s th e sis  t o  pr o v ide visual func tion overse v er al years.3 4 9
Di abeticRetinop athyResearc hers eval uated 759  p atie n t s f rom the RI SE/RIDEPhase III trial s  t o see  if  Lucen ti s ( intra vitrea l  ra nibiz umab,Ge nentec h) ha dan effec t on the severity of apatien t’s d iab etic reti nop a thy .4028 Res ults  showed th ata g reate r p r oport iono fpat i entsin t h e ranibiz u ma b a r m  h ad a two- o r t hre e-ste p r e gressi on o f diabetic retino p athy on the ET DRSs c ale  vs .  tho se  in the sham g rou p. A  three-s te p improveme nt was a ch i evedat 36months  in 3.3 % of the sh am g rou p, compar edto 15.0% a nd  1 3 .2% in  the  0 .3mg a nd 0.5 m g tr e a ted eyes, respec tivel y .  Over the  cour se  of 36m onth s, 33.9% o f the sham- treate d ey es de veloped  p rolife rat iv e diabetic retinopat hy, a s oppos ed  toonl y
 now,_it’s been_granted “humanitarian use,” an_approval pathway_limited_to devices_that_treat or diagnose_fewer than 4,000_people in the US_each year.

The Argus_II_Implant (left) attaches to the retinal surface with a tack. The cable that both_powers_the chip_and_conducts_the image signal from the_episcleral housing is seen temporally._An early_frame of a fluorescein angiogram (right) in a_patient_with the Argus_II Implant demonstrates some persistent macular perfusion. Images: Elaine_Leibenbaum, Julia Haller, MD, and Carl_Regillo, MD.

A few_studies_evaluated_this prosthesis, hopefully paving_the way for its more widespread_use. One study looked at the_safety profile of 16 patients in Europe_who had received the implant.1040/C0017 The_patients were followed on average_for 6.2_months, and reported no surgical_or serious, device-related_adverse effects._Ten patients experienced_no surgery or device-related adverse events_at all, whereas_the other six reported minor adverse_effects,_such as IOP_elevation,_nausea,_fainting, conjunctival_irritation and a_retinal_tear.

A second_study_found that the Argus II implant_has_good long-term reliability, with only one failure_in 30 subjects (each_with_an average of 4.2_years of use, representing more_than 125 cumulative patient years).1037/C0014 Further,_accelerated lifetime_testing demonstrated_that finished implants have more than a 10-year lifetime in accelerated_testing. Another study confirmed these results,_echoing previous tests that_demonstrated the_ability_of the prosthesis_to_provide visual_function over several years.349

Diabetic Retinopathy

Researchers evaluated 759_patients from_the RISE/RIDE Phase III trials to_see if Lucentis (intravitreal_ranibizumab,_Genentech) had an effect on the_severity of a patient’s diabetic retinopathy.4028_Results showed that a greater_proportion_of_patients in the ranibizumab arm_had a two- or three-step regression_of diabetic retinopathy_on the ETDRS scale vs. those in_the_sham group. A three-step improvement was_achieved_at 36 months in 3.3% of_the_sham_group, compared to 15.0% and_13.2% in the 0.3mg and 0.5mg_treated eyes, respectively. Over the course of 36 months,_33.9% of the_sham-treated eyes developed proliferative diabetic_retinopathy,_as_opposed to only