Intraoperative Dexamethasone Implant Improves Outcome of Cataract Surgery With Diabetic Macular Edema

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aniruddha Agarwal, MD, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier:
NCT01546402
First received: March 2, 2012
Last updated: June 17, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Macular Edema, Cystoid
Vision Disorders
Diabetic Macular Edema
Cystoid Macular Edema Following Cataract Surgery
Cataract
Drug: Dexamethasone Drug delivery system (Ozurdex)
Procedure: Cataract surgery
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intraoperative Dexamethasone Implant (Ozurdex®) Improves Outcome of Cataract Surgery in Patients With Diabetic Macular Edema

Resource links provided by NLM:


Further study details as provided by Postgraduate Institute of Medical Education and Research:

Primary Outcome Measures:
  • Change in the Central Macular Thickness [ Time Frame: Baseline and 6 MONTHS ] [ Designated as safety issue: No ]
    The primary outcome is the change in the central macular thickness, either an increase or decrease, as measured by optical coherence tomography as compared to the preoperative thickness.


Secondary Outcome Measures:
  • Change in the Visual Acuity [ Time Frame: Difference in number of letters read (6 months minus baseline) ] [ Designated as safety issue: No ]
    Change in the visual acuity as measured by the Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity scale (number of letters at 6 months - number of letters at baseline) The number of letters read on the ETDRS scale will be measured, with 0 being the worst and 35 being the best


Enrollment: 20
Study Start Date: May 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phacoemulsification with IOL implant
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.
Procedure: 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.
Other Name: Phacoemulsification
Experimental: Phacoemulsification with Ozurdex
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.
Drug: Dexamethasone Drug delivery system (Ozurdex)
It is a sustained release intravitreal implant containing 700µg dexamethasone has been approved by the US-FDA (Food and Drug Administration).
Other Name: Ozurdex

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.

  Eligibility

Ages Eligible for Study:   35 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

The patients of Type 2 Diabetes Mellitus fulfilling the following inclusion criteria shall be enrolled in the study:

  1. Presence of visually significant cataract requiring surgery (any grade)
  2. Patients with Non-proliferative Diabetic Retinopathy (NPDR) with/without clinically significant macular edema (CSME)
  3. Patients with Proliferative Diabetic Retinopathy (PDR) with/without CSME where proliferative component has been adequately treated with laser photocoagulation.

All patients fulfilling criteria 1 with 2 or 3 shall be enrolled in the study. The patients of either sex up to the age of 60 years would be included for the study.

Exclusion Criteria:

The following would be the exclusion criteria:

  • Presence of untreated proliferative diabetic retinopathy
  • Patients with history of ocular hypertension or glaucoma
  • Presence of associated conditions that may exacerbate macular edema, i.e. uveitis, retinal vein occlusions, neovascular glaucoma
  • History of use of drugs such as prostaglandin analogues, adrenaline or nicotinic acid
  • Patients with post-operative media haze or pupillary non-dilation that does not allow good fundus photography, Fundus Fluorescein Angiography (FFA) and Optical Coherence Tomography (OCT).
  • Patients who develop any intraoperative complication including posterior capsular rent, vitreous loss, zonular dehiscence, etc shall be excluded from the study in both the groups
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01546402

Locations
India
Postgraduate Institute of Medical Education and Research
Chandigarh, India, 160012
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
Investigators
Principal Investigator: Vishali R Gupta, MBBS MS Postgraduate Institute of Medical Education and Research
Principal Investigator: ANIRUDDHA K AGARWAL, MBBS Postgraduate Institute of Medical Education and Research
Principal Investigator: Jagat Ram, MBBS MS Postgraduate Institute of Medical Education and Research
Principal Investigator: Amod Gupta, MBBS MS Postgraduate Institute of Medical Education and Research
  More Information

No publications provided

Responsible Party: Aniruddha Agarwal, MD, MBBS, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT01546402     History of Changes
Other Study ID Numbers: aniruddha9
Study First Received: March 2, 2012
Results First Received: April 15, 2014
Last Updated: June 17, 2014
Health Authority: India: Ministry of Health

Additional relevant MeSH terms:
Edema
Cataract
Macular Edema
Vision Disorders
Signs and Symptoms
Lens Diseases
Eye Diseases
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal

ClinicalTrials.gov processed this record on September 30, 2014