Subconjunctival Dexamethasone Implant

8/13/2019 Subconjunctival Dexamethasone Implant

1/24

Subconjunctival dexamethasone

implant

for non-necrotizing scleritis

Heloisa Nascimento1*, Mara Frana1, Luciana Guadalupe Garca2,

Cristina Muccioli1 and Rubens Belfort Jr1


2/24


3/24

Background

Anterior scleritis isusually a chronic,

painful, progressive,

potentially blinding

conditioninvolving both

the episclera and the

sclera.Divided in diffuse,

nodular, and sectorial

scleritis depending on

the clinical appearance

Often associated with

ocular complications

(anterior uveitis,

peripheral keratitis, and

glaucoma), potentially

causing decrease ofvision, and with systemic

connective tissue or

vasculitic diseases, some

of them potentially lethal

Topical eyedrops

frequently are

ineffective. Systemic

administration of

nonsteroidal anti-

inflammatory drugs

(NSAIDs),

corticosteroids,

nonsteroidal

immunosuppressive

agents, or a

combination, is the

mainstay of

treatment for

noninfectious scleritis

Regional steroid injections have been

successfully used

in the treatment of scleritis


4/24

Background

Regional steroids have been avoided in the

treatment of scleritis because of concerns about

the risk of scleral thinning or perforation.

Subconjunctival steroid injections have become part of the

legitimate armamentarium for scleritis treatment in the lastdecade.It may be an attractive adjunct to systemic therapy by

achieving timely improvement while systemic medications

begin to take effect.

Dexamethasone (DEX) 0.7 mg implant (OzurdexW,Allergan, Inc., CA, USA) is a biodegradable implant

approved by FDA. It was designed to be injected into

the eye (vitreous) to treat adults with macular

edema following branch retinal vein occlusion or

central retinal vein occlusion.

This implant represents a newapproach to the treatment of ocular

diseasessince it is capable to

promote a 3-day local pulse therapy

followed by a 6-month gradually

sustained release when it is placed in

the vitreous


5/24

Materials and Methods

Scleritis was diagnosed on the basis of the

characteristic clinical picture of painful

inflammation and tenderness that radiated to

the forehead, brow, jaw, or sinuses, with

edema affecting the episcleral and scleral

tissues, and injection of both the superficial

and deep episcleral vessels.


6/24


Patients with infectious refractory non-

necrotizing anterior diffuse, sectorial, or

nodular scleritis despite adequate treatment

that required steroid therapy were referred

for single-dose DEX 0.7 mg subconjunctival

slow delivery implant according to investigator

judgment.


7/24


Single-dose DEX 0.7 mg implant was performedwith the patient seated at the slit lamp. Beforethe procedure, topical anesthesia and 5% iodine-

povidine solution were instilled. After the procedure, patients received local

prophylactic antibiotic regimen for 7 days.

Patients were followed 1, 7, 15, 30, and 45 days,

and 2, 3, 4, 5, and 6 months post-procedure(visual acuity, intraocular pressure (IOP), anteriorand posterior biomicroscopy, and fundus exams)


8/24

Results

Six patients with non-necrotizing anteriornodular, sectorial, or diffuse refractory scleritiswere included in this study (Table 1). Four

were female and two were male. Mean age was 39.8 years (range 28 to 60

years).

Two patients presented scleritis related torheumatoid arthritis, one probably related totuberculosis, and three were idiopathic.


9/24

Results

All patients were on stable systemic or localtherapy, and no increase to their therapy wasmade prior to enrolment in this study.

In all patients, symptoms disappeared before day7, and most of them were symptoms-free on day2.

One recurrence was noted in the 6-month follow-

up in a patient with rheumatoid arthritis anddiffuse scleritis, and was treated with oralsteroids.


10/24


11/24

Discussion

Nonsteroidal anti-inflammatory drugs can lead to

gastrointestinal issues including ulcers and

gastritis.

Steroidal drugs can worsen systemic conditions as

diabetes and arterial hypertension.

Immunosuppressive agents may have significant

side effects and may not be safe for individualswith comorbidities and those who are pregnant.

Also, it can increase the risk of malignancies.


12/24

Discussion

The Systemic Immunosuppressive Therapy for

Eye Diseases study has recently shown data

regarding the overall mortality or cancer

mortality after treatment with biological

response modifiers (BRM) for inflammatory

diseases. Because of these reasons, BRM

agents are not first-line therapy for scleritis.


13/24

Discussion

OzurdexW (Allergan, Inc.) has already obtained FDAapproval for intravitreal use for macular edema due tononinfectious uveitis or retinal vein occlusions.

It had never been used before for scleritis andsubconjunctivally.

Although patients of this study had been refractory tothe treatment of scleritis, only one recurrence wasnoted in the 6-month follow-up, which suggests that

steroid slow release directly to the sclera can becrucial in scleritis physiopathology and management.


14/24

Discussion

In these cases, one advantage of controlling

scleritis locally is not to expose the patient to

the risks of systemic immunosuppression.

Also, signs and symptoms of the potential

causative disease would not be masked by the

systemic immunosuppression, possibly

allowing the proper diagnosis andmanagement of the potential underlying

disease.


15/24

Discussion

There is also a general concern about IOP

increase with the use of local steroids.

However, it was not noted in any scleritis

patient treated with subconjunctival

dexamethasone implant. More studies need

to be performed to better elucidate this issue.


16/24

Conclusion

Single-dose DEX 0.7 mg implant was safely andeffectively used for the local treatment of non-necrotizing anterior scleritis. Potential advantages

could include easier steroid removal in case ofcomplications such as scleral melting orglaucoma.

Also, it would not mask systemic diseases, signs,

and symptoms, allowing proper diagnosis of thescleritis cause.

Cost-effective relationship should be assessed.


17/24


18/24


19/24

No. Kriteria ya (+), tidak (-)

1. Abstrak 1 paragraf +

2. Mencakup IMRC +

3. Secara keseluruhan Informatif +

4. Tanpa singkatan selain yang baku +

5. Kurang dari 250 kata +


20/24

No. Kriteria Ya (+), tidak (-)

1. Terdiri dari 2 bagian atau 2 paragraf -

2. Paragraf pertama mengemukakan

alasan dilakukan penelitian

+

3. Paragraf ke 2 menyatakan hipotesis

atau tujuan penelitian

-

4. Didukung oleh pustaka yang relevan +

5. Kurang dari 1 halaman +


21/24

No Kriteria Ya (+), tidak (-)

1 Jenis dan rancangan penelitian -

2 Waktu dan tempat penelitian Waktu -, tempat -

3 Populasi sumber -

4 Teknik sampling -

5 Kriteria inklusi +

6 Kriteria eksklusi +

7 Perkiraan & perhitungan besar sampel -

8 Perincian cara penelitian +

9 Blind -

10 Uji statistik -

11 Program komputer - (tidak disebutkan)

12 Persetujuan subjektif + (Inform consent)


22/24

No. Kriteria Ya (+),tidak (-)

1 Jumlah subjek +

2 Tabel karakteristik subjek -

3 Tabel hasil penelitian +

4 Komentar dan pendapat penulis ttg hasil +

5 Tabel analisis data dengan uji -


23/24

No. Kriteria Ya (+), tidak (-)

1 Pembahasan dan kesimpulan terpisah -

2 Pembahasan & kesimpulan dipaparkan dengan jelas +

3 Pembahasan mengacu dari penelitian sebelumnya -

4 Pembahasan sesuai landasan teori +

5 Keterbatasan penelitian -

6 Simpulan utama +

7 Simpulan berdasarkan penelitian -

8 Saran penelitian -

9 Penulisan daftar pustaka sesuai aturan +


24/24

Apakah penelitian ini valid ? Valid

Apakah penelitian ini penting ? Penting untuk

mempertimbangkan alternatif lain dalam pengobatan non-

necrotizing scleritis

Apakah pasien kita terhadap perbedaan dgn subjek penelitian ?

Ya, terdapat perbedaan karakteristik subjek antara di Indonesia

dengan tempat penelitian ini

Apakah terapi tersebut mungkin untuk diterapkan pada pasien

kita ? Perlu dipertimbangkan krn penelitian ini memiliki sampel

yg minimal shg dianggap blm dapat mewakili populasi umum.

Subconjunctival Dexamethasone Implant

Documents