Retreatment With Ozurdex for Macular Edema

8/9/2019 Retreatment With Ozurdex for Macular Edema

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© 2013 Wichtig Editore - ISSN 1120-6721

Eur J Ophthalmol ( 2014; :1 ) 1-924

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Retreatment with Ozurdex for macular edemasecondary to retinal vein occlusion

Gabriel Coscas1 , Albert Augustin 2 , Francesco Bandello3 , Marc D. de Smet 4 , Paolo Lanzetta5 ,Giovanni Staurenghi 6 , Maria Cristina Parravano7 , Patricia Udaondo8 , Elad Moisseiev 9 , Gisele Soubrane10 ,Yossi Yatziv 9 , Anat Loewenstein9

1 Centre Hospitalier Intercommunal de Créteil - France2 Augenklinik, Städtisches Klinikum Karlsruhe - Germany3 Eye Clinic, University Vita-Salute, Scientific Institute San Raffaele, Milan - Italy4 Retina and Inflammation Unit, Clinique De Montchoisi, Lausanne - Switzerland5 Department of Ophthalmology, University of Udine, and Istituto Europeo di Microchirurgia Oculare–IEMO, Udine - Italy6 Department of Biomedical and Clinical Science “Luigi Sacco,” Sacco Hospital, University of Milan, Milan - Italy7 Fondazione G.B. Bietti–IRCCS, Rome - Italy8 Department of Ophthalmology, Nuevo Hospital Universitario y Politecnico La Fe, Valencia - Spain9 Department of Ophthalmology, Tel Aviv Medical Centre, and the Sackler School of Medicine, Tel Aviv University -

Israel10 Department of Ophthalmology, Hotel Dieu, University Paris Centre, Paris - France

ORIGINAL ARTICLE free on line

DOI: 10.5301/ejo.5000376

Purpose: To review the current practice of retreatment with Ozurdex injections in patients with macu-

lar edema (ME) secondary to retinal vein occlusion (RVO), and to recommend simple guidelines for

Ozurdex reinjection in management of RVO.

Methods: This was a multicenter retrospective study of patients who received more than 2 Ozurdex

injections for the treatment of ME in RVO. Recorded parameters included percent of patients with

a 15-letter gain, visual acuity (VA) improvement from baseline, change in central macular thickness

(CMT), time to reinjection, and occurrence of any complications.

Results: A total of 128 patients were included, 58 (45.3%) with central RVO (CRVO) and 70 (54.7%)

with branch RVO (BRVO). Mean interval for Ozurdex reinjection was 5.9 months following the first

injection and 8.7 months following the second. A >15-letter gain in VA was observed in 34 (48.8%)

patients with CRVO and 16 (28%) patients with BRVO. Mean overall VA improvement at month 6 did

not show significance (p>0.05); however, a significantly better mean VA improvement was seen in

treatment-naïve eyes (p


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Ozurdex retreatment in RVO

INTRODUCTION

Retinal vein occlusion (RVO) is a sight-threatening retinal

vascular disorder associated with macular edema (ME) and

neovascularization (1-6). The overall goal of RVO manage-

ment is improvement of patients’ vision, which translates

into improved quality of life. This is achieved by identifying

modifiable risk factors and means of managing them, and

by recognizing and managing sight-threatening complica-

tions. Close monitoring and early intervention has been

shown to effectively reduce retinal complications and the

rate of vision loss (3, 4, 6).

Until recently, the standard of care for branch RVO (BRVO)–

associated ME was grid laser photocoagulation, and ob-

servation was suggested for central retinal vein occlusion

(CRVO)–associated ME. Central RVO with neovasculariza-

tion was treated with scatter laser photocoagulation (3-6).

Over the past decade, advances in retinal imaging tech-

nology and drug development have radically changed the

standard of care (7-16). Two classes of drugs have emerged

as alternative treatments for ME in RVO: corticosteroids

and anti–vascular endothelial growth factor (VEGF) agents.

Superiority of these treatments over the previous standard

of care has been demonstrated in a number of random-

ized, controlled multicenter studies. Intravitreal injection oftriamcinolone acetate was the first treatment shown to im-

prove the visual prognosis in ME secondary to CRVO, and

observation of these patients in no longer an acceptable

option. It was also found to be approximately equal to laser

treatment in ME secondary to BRVO (11, 12).

In 2009, a sustained-release intravitreal 0.7 mg dexa-

methasone delivery system, Ozurdex® (Allergan Inc.,

Irvine, California, USA), was approved for the treatment of

ME secondary to RVO (9, 10). Ozurdex, which contains the

corticosteroid dexamethasone, has demonstrated efficacy

and safety for the treatment of BRVO and CRVO when de-

livered to the vitreous cavity by a sustained-release intra-

vitreal implant (DEX implant; Ozurdex, Allergan, Inc.).

A single intravitreal treatment of 0.7 mg DEX implant was

shown to produce improvements in visual acuity (VA)

already at 30 days post-treatment, which persisted over

90 days, and in many eyes for as long as 6 months; good

tolerance was also observed for a 12-month period, with

significantly less adverse effects compared to triamcino-

lone (9, 10).

Studies of anti-VEGF agents for management of RVO have

specifically used ranibizumab (Lucentis, Genentech Inc.,

South San Francisco, California, USA), which has been

demonstrated to be a safe and effective therapy for MEassociated with both BRVO and CRVO (14-17), and was

subsequently approved for use in RVO in 2012 in Europe.

Efficacy of bevacizumab (Avastin, Genentech Inc.) in the

treatment of ME in RVO was also reported in several un-

controlled studies (18-20), but this anti-VEGF agent is

currently not licensed for use in any ophthalmologic indica-

tions. Also, recent studies have shown positive results for

aflibercept (VEGF Trap-Eye, Eylea, Regeneron, New York,

USA) for the treatment of CRVO (21).

In light of the wide variety of treatment options available for

the treatment of RVO associated with ME, the standard of

care that was used until a few years ago is no longer valid.

The new therapeutics have all been compared to the now

obsolete standard of care that included laser treatment in

BRVO patients with ME and observation alone in CRVO

patients with ME.

However, direct comparisons between the new drugs are

not yet available, and controversy exists regarding the cur-

rent optimal long-term treatment scheme for ME in RVO. A

guideline for first-line therapy of RVO has been proposed

in a consensus paper published in 2011 (8) but did not ad-

dress retreatment.

Today, studies and experience from clinical practice haveshown that both corticosteroids and anti-VEGF agents

usually require long-term repeated treatments in order

to control the ME, prevent vision loss, and increase the

chance of visual improvement.

Criteria for the retreatment of ME in RVO have yet to be

defined, and there are currently no established protocols

for long-term management of these patients.

Ozurdex is a promising treatment option for ME in RVO.

Being a slow-release implant, its pharmacokinetics enable

high concentrations of dexamethasone to be sustained

in the retina and vitreous during the first 2-3 months af-

ter Ozurdex injection, and lower concentrations are sus-

tained up to 6 months (22). Therefore, long-term therapy

with Ozurdex will require significantly fewer injections

compared with anti-VEGF agents, which need to be ad-

ministered as frequently as once a month for an optimal VA

outcome (14-17).

Existing Ozurdex studies have not directly addressed

the question of the optimum retreatment interval for the

Ozurdex® implant 0.7 mg or safety after long-term re-

peated injections. The time course and magnitude of the

response to Ozurdex treatment suggests that some eyes


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© 2013 Wichtig Editore - ISSN 1120-6721 3

Coscas et al

are undertreated and that physicians may want to evalu-

ate their patients for retreatment earlier (before 180 days)than the current pivotal studies indicate. Today, in clinical

practice, many patients are being treated before month

6, at their physician’s discretion.

The purpose of this study was to demonstrate real-life data

on repeated use of Ozurdex in patients with RVO, i.e., 2

or more injections during at least 1 year of follow-up, and

evaluate its efficacy and safety. In addition, we suggest a

simple algorithm for its repeated use. Efficacy outcomes

were BCVA and central macular thickness (CMT), and

safety outcomes were intraocular pressure (IOP) and cata-

ract development.

METHODS

Patient selection

Patient data were collected from 9 participating retina clin-

ics all over Europe. The study was approved by the insti-

tutional review boards of all institutions. Included patients

had received at least 2 Ozurdex injections for the treat-

ment of ME secondary to RVO between August 1, 2010,

and July 31, 2012. All patients had at least 6 months offollow-up after the last injection. A minimal VA of 20/200 at

baseline was required for inclusion in the study.

Eyes with documentation of severe macular ischemia on

fluorescein angiography were excluded. Patients with ad-

ditional ophthalmic comorbidity, which could have had

a considerable influence on VA, were excluded from this

analysis. Specifically, patients with any history of advanced

age-related macular degeneration (AMD), diabetic macu-

lar edema (DME), proliferative diabetic retinopathy (PDR),

advanced glaucoma, optic neuropathy, or corneal opacity

were not included. Also, patients with previous ocular trau-

ma or vitrectomy were excluded. Patients who participated

in other therapeutic studies during the time period of this

study were also excluded.

Data collection

Data were retrieved by retrospective review of the patients’

medical charts. Collected parameters included demo-

graphic information, previous ocular history, type of RVO,

number and dates of Ozurdex injections, additional treat-

ments for RVO-associated ME (before and after Ozurdex

administration), VA and IOP throughout the study period,

and the occurrence of any complications. Data regardingCMT and presence of intraretinal fluid from OCT scans

were also included when available.

Outcome measures

Primary outcome measures were VA improvement from

baseline, the percentage of patients with a 15-letter gain,

and change in CMT following at least 2 Ozurdex injections.

Secondary outcome measures included IOP measured

5-7 months after the last injection, the time to reinjection,

and the incidence of any adverse effects following re-

peated injections. Recorded adverse events included IOP

elevation, cataract progression, retinal detachment (RD),

vitreous hemorrhage (VH), and endophthalmitis.

Statistical analysis

For statistical analysis, all visual acuity values were con-

verted to the logMAR scale. According to Holladay (23)

and the University of Freiburg study group results (24),

blindness was set at 0.00125/2.9 (decimal/logMAR), light

perception al 0.0025/2.6, hand movements at 0.005/2.3,

and counting fingers at 0.014/1.85.t Test was used to compare continuous variables between

groups. Chi-square test was used to analyze associations

between categorical parameters. A p value of 0.05 was

used to declare statistically significant difference between

groups for all analyses. Data were analyzed using SPSS

for Windows version 15 (SPSS Inc., Chicago, Illinois, USA).

RESULTS

Included in the study were 128 eyes of 128 patients who

fulfilled the inclusion criteria. Of the 128 eyes, 58 (45.3%)

had ME secondary to BRVO and 70 (54.7%) had ME sec-

ondary to CRVO. Patients included 75 (58.6%) men and 53

(41.4%) women, with a mean age of 65.8 ± 12.9 years (range

27-101 years). The duration of ME was under 6 months

in 62 (48.4%) patients. Previous treatment had been ad-

ministered for 68 (53.1%) eyes. These included 39 (30.2%)

eyes that were previously treated with anti-VEGF injections,

9 (7%) eyes with laser treatment, 8 (6.2%) eyes with both

anti-VEGF and laser, and 10 (7.8%) eyes with other steroid

treatment (Fig. 1).


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Effect of repeated injections on visual acuity

At baseline, mean VA of all patients was 0.42 ± 0.32. An im-

provement of 15 letters or more after the first 2 injections of

Ozurdex was achieved in 50 (39%) patients. These includ-

ed 34 (48.8%) patients with CRVO and 16 (28%) patients

with BRVO. A loss of 15 letters or more was observed in 13

(10%) patients, which included 8 (12.2%) of the patients

with CRVO and 5 (8%) of those with BRVO (Fig. 2).

Mean final VA, measured at the last follow-up visit between

5 and 7 months after the last injection, was 0.48 ± 0.38,

with no significant difference (p = 0.13). In patients with

BRVO, mean baseline VA was 0.44 ± 0.27 and final VA was

0.48 ± 0.27. In patients with CRVO, mean baseline VA was

0.41 ± 0.36 and final VA was 0.489 ± 0.46. The differences

were not statistically significant (p = 0.24 and p = 0.14,

respectively).

Repeated Ozurdex injections achieved a better mean

final VA improvement in treatment-naive eyes when com-

pared to eyes that were previously treated for ME. A trend

towards better final VA in these eyes was noted (p = 0.06)

(Tab. I). Although this parameter did not reach statistical

significance, the change in VA compared to baseline was

significantly greater in treatment-naive eyes (p = 0.03).

Effect of repeated injections on retinalthickness

Following repeated Ozurdex injections, CMT continued to

decline significantly after the second injection, showing a

positive response to retreatment.

At the final follow-up, for CRVO patients with a baseline

CMT of 629.4 ± 191.2 µm, the mean change in CMT was

−355.1 µm. For BRVO patients with a baseline CMT of

507.5 ± 158.0 µm, the mean change in CMT was −214.6 µm

(p


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Coscas et al

No significant difference in CMT reduction was noted be-

tween treatment-naive eyes and those that had undergone

previous treatments.

Timing of reinjection

The mean time between the first and second Ozurdex in-

jections was 175.7 days (approximately 5.9 months, range

3-23 months), and between the second and third injections,

261.7 days (approximately 8.7 months, range 3-16 months)(Fig. 4). The interval between the first and second Ozurdex

injections was under 5 months in 71 (55.4%) patients, and

7 months or longer in 25 (19.5%) patients.

Safety of repeated injections

No safety issues were observed following more than

2 injections of Ozurdex. The IOP increases were transient

and easily handled with medications. Intraocular pressure

increases of >10 mm Hg or >25 mm Hg were seen in 9

(7%) patients, and 21 patients (16.4%) required medical

treatment during the study period. Cataract progression

occurred in 3.9% of patients. No cases of RD, VH, or en-

dophthalmitis were encountered in any of these patients.

DISCUSSION

The GENEVA study has demonstrated the safety of

retreatment with Ozurdex for both BRVO and CRVO.

Following 2 DEX implants, the incidence of adverse

events was similar to that of those who received a single

DEX implant, except for a greater number of patients with

cataract progression, 29.8% compared to 10.5%, andIOP elevation of more than 10 mm Hg, 15.4% compared

to 12.6% (9, 10). Cataract extraction was performed in

only 1.3% of the patients who received 2 DEX implants;

IOP increases were usually transient and controlled with

medication or observation. Acute treatment-related seri-

ous adverse events, including VH, endophthalmitis, and

RD, were extremely rare following both initial and second

injections (9, 10).

Regarding efficacy, the beneficial effects of treatment on

VA and macular thickening were similar after the first and

second injections of DEX implants. However, the decline

in benefit observed in some eyes before the 6-month as-

sessment led the investigators to conclude that some

eyes were undertreated and that evaluation for retreat-

ment should occur earlier than 6 months (10).

A number of small, single-center retrospective series

have recently documented the efficacy and safety of re-

peated treatments with Ozurdex on an as-needed basis

(25-30). Improvements in VA measured at the time of

peaking efficacy following the second implant were simi-

lar to those following the first implant, with no increase in

serious adverse effects (25-30). It has also been shown

that 1 or 2 injections of Ozurdex are not associated withany complications in the long term, and may have a ben-

eficial effect on long-term visual prognosis (31).

Our study was designed to evaluate the results of current

practice with repeated Ozurdex injections and analyze the

long-term outcome of efficacy and safety after at least 2

or more injections. Based on these study results, evaluat-

ing patient data from clinical practice, Ozurdex is shown

to be both effective and well-tolerated after multiple re-

treatments.

A marked improvement of 15 letters or more was recorded

after the first 2 injections of Ozurdex in 39% of patients.

These included 34 (48.8%) patients with CRVO and 16

(28%) patients with BRVO. Mean initial VA was not sig-

nificantly different between CRVO and BRVO patients, and

a higher rate of VA improvement of 15 letters or more in

CRVO patients repeatedly treated with Ozurdex has also

been reported in another study (29).

Another f inding of our study is that Ozurdex retreatment

achieved a greater improvement in VA in treatment-

naive eyes 5-7 months after last injection, compared to

previously treated eyes (Tab. I), in which the overall im-

provement of VA at this time was not significant. This is

Fig. 4 - Mean intervals (in months) between the first and second

Ozurdex injections and between the second and third Ozurdex in-

jections.


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not surprising, since previously treated eyes have had

a longer duration and more aggressive disease. It alsoindicates that Ozurdex retreatment may be an effective

first-line treatment regimen for eyes with ME secondary

to RVO, and strengthens the need for establishing an op-

timal protocol for repeated injections.

Interestingly, the time to retreatment was approximately

5.5 months, which is a longer treatment interval than report-

ed in previous studies, which ranged from 3.2 to 5.5 months

(25-30). As mentioned, it has previously been suggested that

the optimal interval for repeated Ozurdex injection can be

less than 6 months. Our results of VA gain in general popu-

lation of patients with ME due to RVO at 5-7 months after

the last injection support this notion, as the long intervals

achieved no significant change in mean VA at this time. The

collected data in this retrospective multicenter study dem-

onstrate that the absence of standardized criteria for retreat-

ment with Ozurdex has a significant impact on the timing of

the repeated injections, which is highly variable.

Following repeated Ozurdex injections, CMT showed a

good response to treatment and continued to decline sig-

nificantly after the second Ozurdex injection.

Overall, CMT was significantly reduced from a baseline

mean of 568.45 ± 186.4 µm to 284.85 ± 174.6 µm, which

represents a mean reduction of 50.1% (p


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Coscas et al

would result in 2 or 3 injections per year, much less than that

required with anti-VEGF injections (32-34).

Our study includes the largest series of patients treated

with at least 2 Ozurdex injections. The information pro-

vided reflects the current practice patterns of retreat-

ment with Ozurdex injections in Europe. It seems that

repeated Ozurdex injection is a valid treatment option

of ME in RVO, accepted by both clinicians and pa-

tients. However, indications and protocols for reinjec-

tions have not been clarified and marked variation ex-

ists in the timing of repeated injections. Although it is

generally accepted that due to its pharmacokinetic and

clinical profiles, Ozurdex should be reinjected withinless than 6 months after the previous injection, our re-

sults indicate that in many cases it is reinjected after

6 months or more. The retreatment intervals in current

practice may be too long, and a shorter treatment in-

terval may allow Ozurdex to reach its full potential ef-

ficacy after multiple injections. As a general rule, the

decision to retreat, with any drug, should be based on

both functional (VA) and morphologic (OCT) criteria. As

such, retreatment should be considered when VA dete-

riorates or if persistent ME is documented by OCT (and

fluorescein angiography in case of doubt).

Therefore, we have established the following recom-

mendations for the treatment of ME in RVO with Ozur-

dex. The suggested retreatment algorithm is based on

the joint clinical experience of the authors, as well as

on data from this and other recent studies on this issue.

After baseline VA, complete examination, and imaging

have been performed, an Ozurdex injection is admin-

istered. In patients with BRVO, but not CRVO, laser

treatment can be considered in combination with the

injections, at the physician’s discretion.

Following an Ozurdex injection, IOP should be moni-

tored between 4 to 8 weeks, and this monitoring can

be done by the local physician or a nurse at the closestclinic. If an IOP rise >10 mm Hg or ≤30 mm Hg occurs,

treatment should be initiated with IOP-lowering agents

and the patient followed monthly until IOP returns to

normal. If a patient experiences blurred vision or pain,

he or she should contact the clinic immediately.

A complete examination including VA and OCT imaging

should be performed 3 months after an Ozurdex injec-

tion. According to the findings in the examination, a re-

peated Ozurdex injection should be performed if ME is

still present or if VA has decreased. With this strategy

(Fig. 5), repeated injection can be administered from 3

to 6 months (or more), according to the patient’s indi-

vidual clinical course.

If there is ME and VA has improved 6 months after the

injection, monitoring should be continued without rein-

ject ion. This protocol may allow for adequate monitor-

ing of such patients, early recognition of sight-threat-

ening complications, and timely reinjections tailored

to each patient’s needs. If ME is present even without

VA decrease, reinject ion may be considered in order to

achieve greater VA improvement.

Based on available data from this and other studies

(25-29), reinjections generally will be performed after4 to 5 months, with a mean of approximately 2-3 injec-

tions per year. We recommend applying this suggested

protocol until large-scale, randomized, controlled trials

addressing this issue are conducted.

Financial Support: No financial support was received for this submis-

sion.

Conflict of Interest Statement: None of the authors has conflict of

interest with this submission.

Address for correspondence:

Prof. Gabriel Coscas

Centre Hospitalier Intercommunal de Créteil

40 Avenue de Verdun

94000 Créteil

France

[email protected]

Fig. 5 - Ozurdex retreatment strategy. IOP = intraocular pressure;

ME = macular edema; VA = visual acuity.


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Retreatment With Ozurdex for Macular Edema

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