Clinical trial NCT01546402
Conditions: Macular Edema, Cystoid Vision Disorders Diabetic Macular Edema Cystoid Macular Edema Following Cataract Surgery Cataract
Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh
Start date: 2011-05-01; Completion date: 2012-11-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is undertaken to determine the effect of intravitreal long acting dexamethasone implant, (Ozurdex®) in improving outcome of cataract surgery in patients with diabetic macular edema.

Diabetic Macular Edema and cataract constitute important causes of visual impairment in patients with diabetes. Cataract surgery in patients with diabetic retinopathy is associated with progression of retinopathy.

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 edema.

Intravitreal Triamcinolone Acetonide (TA), a water insoluble steroid, has been shown to reduce the retinal thickness and improve the visual acuity. However, recurrence of macular edema in patients who receive intravitreal TA is a major concern as the patients need multiple repeat injections.

In search for the ideal corticosteroid preparation, a Dexamethasone Posterior Segment Drug Delivery System (Dexamethasone DDS - Ozurdex®, Allergan Inc, Irvine, California) was recently developed. 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.

Detailed 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.

Arms: arm 1: This group (Group B) includes patients who will undergo phacoemulsification with intraocular lens implantation. The dexamethasone implant will not be injected at the beginning of cataract surgery. Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy. arm 2: This group (Group A) includes patients who will undergo phacoemulsification with intraocular lens implantation with intraoperative long acting steroid injection (Ozurdex ®). The dexamethasone implant will be injected at the beginning of cataract surgery, 4mm from the limbus using the specially designed injector. Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy.
Interventions: intervention 1: Dexamethasone Drug delivery system (Ozurdex) intervention 2: Cataract surgery
Intervention descriptions: intervention 1: It is a sustained release intravitreal implant containing 700µg dexamethasone has been approved by the US-FDA (Food and Drug Administration). intervention 2: Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy.

Protocol documents: