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

• Sponsor: Raj K. Maturi, MD (Other)
• Overall Status: Completed
• CT.gov ID: NCT02036424
• Collaborator: Allergan (Industry)
• Enrollment: 45
• Location: 1
• Arms: 2
• Duration (Months): 19
• Patients Per Site Per Month: 2.4

Study Details

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
• 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: Jan 1, 2014
• Actual Primary Completion Date: Aug 1, 2015
• Actual Study Completion Date: Aug 1, 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 Names: 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 Names: Dexamethasone Intravitreal Implant

Outcome Measures

Primary Outcome Measures

1. Mean Visual Acuity Change [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 [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

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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: Jan 15, 2014
• Last Update Posted: Dec 1, 2015
• Last Verified: Nov 1, 2015

• Additional relevant MeSH terms: Macular Edema; Edema; Dexamethasone; Bevacizumab

Study Results

Participant Flow

Recruitment Details	Subjects were recruited from the PI's clinical practice from January 2014 through October 2014.
Pre-assignment Detail	This trial had 50 study eyes from a total of 45 participants. 5 participants had both eyes in the study.

Arm/Group Title	Bevacizumab	Ozurdex
Arm/Group Description	1.25 mg intravitreal injection given monthly during a 6 month period Bevacizumab: antiVEGF	Dexamethasone intravitreal implant, 0.7 mg given every 3 months over 6 month period with a maximum of 3 injections Ozurdex: intravitreal steroid
Period Title: Overall Study
STARTED	23	27
COMPLETED	23	27
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Bevacizumab	Ozurdex	Total
Arm/Group Description	1.25 mg intravitreal injection given monthly during a 6 month period Bevacizumab: antiVEGF	Dexamethasone intravitreal implant, 0.7 mg given every 3 months over 6 month period with a maximum of 3 injections Ozurdex: intravitreal steroid	Total of all reporting groups
Overall Participants	23	27	50
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	14 60.9%	11 40.7%	25 50%
>=65 years	9 39.1%	16 59.3%	25 50%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61 (9)	65 (11)	63 (10)
Sex: Female, Male (Count of Participants)
Female	10 43.5%	15 55.6%	25 50%
Male	13 56.5%	12 44.4%	25 50%
Region of Enrollment (study eyes) [Number]
United States	23	27	50

Outcome Measures

1. Primary Outcome

Title	Mean Visual Acuity Change
Description	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.
Time Frame	baseline to month 7

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bevacizumab	Ozurdex
Arm/Group Description	1.25 mg intravitreal injection given monthly during a 6 month period Bevacizumab: antiVEGF	Dexamethasone intravitreal implant, 0.7 mg given every 3 months over 6 month period with a maximum of 3 injections Ozurdex: intravitreal steroid
Measure Participants	23	22
Measure eyes	23	27
Mean (Standard Deviation) [ETDRS letters]	5.6 (6.1)	5.8 (7.6)

2. Primary Outcome

Title	Change in Optical Coherence Tomography (OCT) Central Subfield Thickness (CST) From Baseline to Month Seven
Description	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.
Time Frame	baseline to month seven

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bevacizumab	Ozurdex
Arm/Group Description	1.25 mg intravitreal injection given monthly during a 6 month period Bevacizumab: antiVEGF	Dexamethasone intravitreal implant, 0.7 mg given every 3 months over 6 month period with a maximum of 3 injections Ozurdex: intravitreal steroid
Measure Participants	23	22
Measure study eyes	23	27
Mean (Standard Deviation) [microns]	-13 (105)	-122 (120)

Adverse Events

Adverse Event Reporting Description	Data entered is based on number of study eyes rather than number of participants. Systemic serious adverse events are reported based on the number of participants (45), ophthalmic AEs are based on number of study eyes (50)
Arm/Group Title	Bevacizumab		Ozurdex
Arm/Group Description	1.25 mg intravitreal injection given monthly during a 6 month period Bevacizumab: antiVEGF		Dexamethasone intravitreal implant, 0.7 mg given every 3 months over 6 month period with a maximum of 3 injections Ozurdex: intravitreal steroid
All Cause Mortality
	Bevacizumab		Ozurdex
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Bevacizumab		Ozurdex
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/23 (30.4%)		3/22 (13.6%)
Cardiac disorders
bradycardia	1/23 (4.3%)	1	0/22 (0%)	0
congestive heart failure	0/23 (0%)	0	1/22 (4.5%)	1
Eye disorders
vitreous hemorrhage	2/23 (8.7%)	2	1/22 (4.5%)	1
cranial nerve VI palsy	1/23 (4.3%)	1	0/22 (0%)	0
choroidal detachment	0/23 (0%)	0	1/22 (4.5%)	1
Gastrointestinal disorders
colon cancer	1/23 (4.3%)	1	0/22 (0%)	0
Renal and urinary disorders
pyelonephritis	1/23 (4.3%)	1	0/22 (0%)	0
Respiratory, thoracic and mediastinal disorders
pneumonia	1/23 (4.3%)	1	0/22 (0%)	0
Other (Not Including Serious) Adverse Events
	Bevacizumab		Ozurdex
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/23 (43.5%)		15/27 (55.6%)
Eye disorders
epiretinal membrane	0/23 (0%)	0	2/27 (7.4%)	2
vitreous syneresis	2/23 (8.7%)	2	3/27 (11.1%)	3
posterior capsule opacification	2/23 (8.7%)	2	4/27 (14.8%)	4
vitreous hemorrhage	5/23 (21.7%)	5	2/27 (7.4%)	2
worsening of cataract	4/23 (17.4%)	4	7/27 (25.9%)	7
increased intraocular pressure	0/23 (0%)	0	14/27 (51.9%)	14

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.