Anti-Vascular Endothelial Growth Factor (Anti-VEGF) Alone Versus Ozurdex Given Every 3 Months for Treatment of Persistent Diabetic Macular Edema

• ClinicalTrials.gov Identifier: NCT02036424
• Recruitment Status: Completed
• First Posted: January 15, 2014
• Results First Posted: November 3, 2015
• Last Update Posted: December 1, 2015
• Sponsor: Raj K. Maturi, MD
• Collaborator: Allergan
• Information provided by (Responsible Party): Raj K. Maturi, MD, Maturi, Raj K., M.D., P.C.

Study Description

Brief Summary:

To determine if there is visual benefit with Ozurdex treatment every three months compared to monthly anti-VEGF alone, in subjects with persistent diabetic macular edema. The investigator hypothesizes more frequent administration of Ozurdex in patients that have persistent diabetic macular edema will result in a more rapid and sustained improvement of visual acuity and/or optical coherence topography (OCT) compared to the use of anti-VEGF alone.

Condition or disease	Intervention/treatment	Phase
Diabetic Macular Edema	Drug: Ozurdex; Drug: Bevacizumab	Phase 4

Detailed Description:

Statistics throughout this study referred to the number of eyes rather than the number of subjects. Subjects were allowed to have both eyes in the study provided that inclusion/exclusion criteria were met. Five subjects had both eyes in the study; 45 subjects were actually enrolled, resulting in 50 study eyes.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 45 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: A 10 Month, Single Masked, Randomized Controlled Study to Assess Anti-VEGF Alone Versus Ozurdex Given Every 3 Months for Treatment of Persistent Diabetic Macular Edema
• Study Start Date: January 2014
• Actual Primary Completion Date: August 2015
• Actual Study Completion Date: August 2015

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Bevacizumab; 1.25 mg intravitreal injection given monthly during a 6 month period	Drug: Bevacizumab; antiVEGF; Other Name: Avastin
Active Comparator: Ozurdex; Dexamethasone intravitreal implant, 0.7 mg given every 3 months over 6 month period with a maximum of 3 injections	Drug: Ozurdex; intravitreal steroid; Other Name: Dexamethasone Intravitreal Implant

Outcome Measures

Primary Outcome Measures :

1. Mean Visual Acuity Change [ Time Frame: baseline to month 7 ]
   Visual acuity was obtained using ETDRS method and the total number of letters correct using that method was used to calculate mean visual acuity change.
2. Change in Optical Coherence Tomography (OCT) Central Subfield Thickness (CST) From Baseline to Month Seven [ Time Frame: baseline to month seven ]
   Optical coherence tomography (OCT) is an established medical imaging technique that uses light to capture micrometer-resolution, three-dimensional images. The image is presented in grid form which divides that retina into sections. The center most section (CST) is used for this outcome measurement.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Male of female age 18 years or older
2. Type 1 or Type 2 diabetes
3. Best corrected visual acuity (BCVA) score of >24 and <78 letters
4. History of at least 3 anti-VEGF intravitreal injections over the past 5 months
5. Presence of macular edema defined as central subfield thickness of >340 microns on Cirrus OCT

Exclusion Criteria:

1. Anti-VEGF intravitreal treatment in the last 4 weeks
2. Intravitreal steroid treatment in the last 8 weeks or Ozurdex in the last 4 months
3. Pan retinal photocoagulation (PRP) or focal laser in the last 4 months
4. Active iris neovascularization
5. Any ocular condition in the study eye that, in the opinion of the investigator, is severe enough to compromise the study result
6. Uncontrolled systemic disease
7. Known history of intraocular pressure (IOP) elevation in response to corticosteroid treatment, that is not controlled on 2 glaucoma medications
8. Current enrollment in an investigational drug study or participation in such a study within 30 days prior to the baseline visit
9. Female patients who are pregnant, nursing or planning a pregnancy or who are of childbearing potential and not using a reliable means of contraception
10. Any condition or reason (including inability to read early treatment diabetic retinopathy study (ETDRS) chart or language barrier) that precludes the patient's ability to comply with study requirements including completion of the study
11. Patients with active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases.
12. Aphakia or pseudophakia with anterior chamber intraocular lens
13. Hypersensitivity to any components of Ozurdex or Avastin

Contacts and Locations

Locations

United States, Indiana

Raj K Maturi MD PC

Indianapolis, Indiana, United States, 46290

Sponsors and Collaborators

Raj K. Maturi, MD

Allergan

Investigators

• Principal Investigator: Raj K Maturi, MD; Raj K. Maturi, MD, PC

More Information

• Responsible Party: Raj K. Maturi, MD, Raj K. Maturi MD, PI, Maturi, Raj K., M.D., P.C.
• ClinicalTrials.gov Identifier: NCT02036424
• Other Study ID Numbers: OA 003
• First Posted: January 15, 2014
• Results First Posted: November 3, 2015
• Last Update Posted: December 1, 2015
• Last Verified: November 2015

Additional relevant MeSH terms:

Macular Edema; Edema; Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases; Dexamethasone; Bevacizumab; Antineoplastic Agents, Immunological; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Physiological Effects of Drugs; Growth Inhibitors; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal