Intraoperative Dexamethasone Implant (Ozurdex®) Improves Outcome of Cataract Surgery in Patients With Diabetic Macular Edema
Description:
Diabetic Macular Edema (DME) and cataract constitute important causes of visual impairment in
patients with diabetes mellitus. Cataract surgery in patients with diabetic retinopathy is
associated with progression of both retinopathy and maculopathy in nearly 23-57% of cases,
thus affecting the final visual outcome. Post-cataract surgery, macular edema may be due to
worsening/presence of pre-existing clinically significant macular edema (CSME) or due to
development of Irvine Gass Syndrome where cystoid macular edema (CME) occurs in the post
operative period and is believed to be inflammatory in origin. Focal/ grid laser
photocoagulation is the standard of care in the management of CSME, which may be pre-existing
at the time of cataract surgery or worsens following surgery. Several adjuncts including
intravitreal corticosteroids, Pegaptanib Sodium (Macugen; Pfizer, New York), Ranibizumab
(Lucentis; Genentech, South San Francisco, California), Bevacizumab (Avastin, Genentech) have
been tried in an attempt to improve the visual results.
Several modalities such as non-steroidal anti-inflammatory agents, carbonic anhydrase
inhibitors, corticosteroids, hyperbaric oxygen, laser photocoagulation and vitrectomy with
internal limiting membrane peeling have been tried for managing inflammatory cystoid macular
edema13. Intravitreal Triamcinolone Acetonide (TA), a water insoluble steroid, has been shown
to reduce the retinal thickness and improve the visual acuity14-16. However, recurrence of
macular edema in patients who receive intravitreal TA is a major concern as the patients need
multiple repeat injections because of the short half life of the drug (18.6 days). A more
potent steroid, dexamethasone has also been tried as an alternative to TA for macular edema;
however, its short half life of only 3 hours prevents its clinical application.
In search for the ideal corticosteroid preparation, a Dexamethasone Posterior Segment Drug
Delivery System (DDS) – Ozurdex®, Allergan Inc, Irvine, California) was recently developed
which has generated new interest in this molecule. It is a sustained release intravitreal
implant containing 700µg dexamethasone has been approved by the US-FDA (Food and Drug
Administration) for treatment of macular edema in retinal vein occlusions. Promising results
have been shown in certain patients with persistent diabetic macular edema receiving this
intravitreal drug delivery system with improvement in visual acuity.
The present study introduces a novel concept of using intraoperative Ozurdex ® implant in
patients with diabetes mellitus while undergoing cataract surgery to minimize the worsening
of diabetic maculopathy.
Condition:
Macular Edema, Cystoid
Treatment:
Dexamethasone Drug delivery system (Ozurdex)
Start Date:
May 2011
Sponsor:
Postgraduate Institute of Medical Education and Research
For More Information:
https://clinicaltrials.gov/show/NCT01546402