Diabetic Macular Edema Treated With Ozurdex (DMEO)

• Sponsor: Johns Hopkins University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01951066
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Duration (Months): 26
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

To measure various pro-permeability factors in the aqueous humor of patients with persistent/recurrent diabetic macular edema

Condition or Disease	Intervention/Treatment	Phase
Diabetic Macular Edema	Drug: Dexamethasone Implant; Drug: Anti-VEGF injection	Phase 2

Detailed Description

Patients with Diabetic Macular Edema (DME) are increasingly being treated with molecules targeting vascular endothelial factor (VEGF). One potential advantage of a dexamethasone implant over specific VEGF antagonists is that steroids suppress production of multiple pro-permeability factors.

Our primary objective is to measure the pro-permeability factors in the aqueous humor of patients with persistent/recurrent macular edema despite prior treatment with anti-VEGF agents at baseline and at 1, 2, 3, and 4 months after intraocular injection of a dexamethasone implant.

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Official Title: Diabetic Macular Edema Treated With Ozurdex (DMEO)
• Study Start Date: Oct 1, 2013
• Actual Primary Completion Date: Dec 1, 2015
• Actual Study Completion Date: Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1 (dexamethasone implant/anti-VEGF) Patients in group 1 received an injection of an dexamethasone implant at baseline followed by PRN anti-VEGF injections after crossover at week 16.	Drug: Dexamethasone Implant; Patients will receive a single injection of a dexmethasone implant; Drug: Anti-VEGF injection; Patients will receive PRN injections of an anti-VEGF agent
Experimental: Group 2 (anti-VEGF/dexamethasone implant) Patients in group 2 received prn anti-VEGF injections followed by injection of a dexamethasone implant after crossover at week 16.	Drug: Dexamethasone Implant; Patients will receive a single injection of a dexmethasone implant; Drug: Anti-VEGF injection; Patients will receive PRN injections of an anti-VEGF agent

Outcome Measures

Primary Outcome Measures

1. Correlation Between Change in Level of Propermeability Factors With Change in Edema After Treatment With a Dexamethasone Implant or Anti-VEGF Agent [1, 2, 3, and 4 months after injection of a dexamethasone implant or anti-VEGF agent]

   Changes in propermeability factor levels were correlated with changes in edema using the person correlation coefficient (this was calculated using data from all time points).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• • Signed informed consent and authorization of use and disclosure of protected health information

• Age more than or equal to 18 years

• Diagnosis of diabetic macular edema

• Intraretinal or subretinal fluid in the macula determined by Spectralis OCT

• Best corrected visual acuity score in the study eye of 20/30 to 20/400 inclusive (Snellen equivalents using the ETDRS protocol at a distance of 4 meters)

• In the opinion of the investigator, decreased vision in the study eye is due to foveal thickening from DME and not from other obvious causes of decreased vision

• Persistent or recurrent edema despite prolonged treatment with an anti-VEFG agent

Exclusion Criteria:

• • Scatter laser photocoagulation or macular photocoagulation within 3 months of study entry in the study eye

• Intraocular surgery in the study eye within 3 months of study entry

• Use of intraocular or periocular injection of steroids in the study eye (e.g., triamcinolone) within 4 months of study entry

• Previous use of an anti-VEGF drug within 1 month of study entry

• Yttrium-Aluminum-Garnet (YAG) laser capsulotomy within 1 month of study entry

• Any condition that the investigator believes would pose a significant hazard to the subject if investigational therapy were initiated.

• Inability to comply with study or follow up procedures

• History of glaucoma. (Patients who have undergone filtration surgery may be included)

• Patients with active or suspected ocular or periocular infection, including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases.

• Aphakic eyes with rupture of the posterior lens capsule.

• Eyes with ACIOL and rupture of the posterior lens capsule.

• Patients with hypersensitivity to dexamethasone or to any other components of the product

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wilmer Eye Institute	Baltimore	Maryland	United States	21287

Sponsors and Collaborators

• Johns Hopkins University

Investigators

• Principal Investigator: Peter A Campochiaro, MD, Johns Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Peter A Campochiaro, MD, Professor of Ophthalmology and Neuroscience, Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT01951066
• Other Study ID Numbers: DMEO-001
• First Posted: Sep 26, 2013
• Last Update Posted: Sep 29, 2016
• Last Verified: Aug 1, 2016

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

Study Results

Participant Flow

Arm/Group Title	Group 1 (Dexamethasone Implant/Anti-VEGF)	Group 2 (Anti-VEGF/Dexamethasone Implant)
Arm/Group Description	Patients in group 1 received an injection of an dexamethasone implant at baseline followed by PRN anti-VEGF injections after crossover at week 16. Dexamethasone Implant: Patients will receive a single injection of a dexmethasone implant Anti-VEGF injection: Patients will receive PRN injections of an anti-VEGF agent	Patients in group 2 received prn anti-VEGF injections followed by injection of a dexamethasone implant after crossover at week 16. Dexamethasone Implant: Patients will receive a single injection of a dexmethasone implant Anti-VEGF injection: Patients will receive PRN injections of an anti-VEGF agent
Period Title: First Intervention (Baseline to Week 16)
STARTED	10	10
COMPLETED	10	10
NOT COMPLETED	0	0
Period Title: First Intervention (Baseline to Week 16)
STARTED	10	10
COMPLETED	10	10
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	All Participants
Arm/Group Description
Overall Participants	20
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	61.8
Sex: Female, Male (Count of Participants)
Female	6 30%
Male	14 70%
Baseline Intraretinal Fluid (participants) [Number]
Mild	3 15%
Moderate	14 70%
Severe	3 15%
Mean Disease Duration (Months) [Mean (Full Range) ]
Mean (Full Range) [Months]	48.1
Prior Anti-VEGF injections (Injections) [Mean (Full Range) ]
Mean (Full Range) [Injections]	13.3
Prior Intraocular Steroids (participants) [Number]
Number [participants]	5 25%
Prior Laser (participants) [Number]
Grid Laser	6 30%
Scatter Laser Photocoagulation	6 30%
Baseline Best Corrected Visual Acuity (ETDRS Score) [Mean (Full Range) ]
Mean (Full Range) [ETDRS Score]	56.1
Baseline Central Subfield Thickness (Microns) [Mean (Full Range) ]
Mean (Full Range) [Microns]	464.3

Outcome Measures

1. Primary Outcome

Title	Correlation Between Change in Level of Propermeability Factors With Change in Edema After Treatment With a Dexamethasone Implant or Anti-VEGF Agent
Description	Changes in propermeability factor levels were correlated with changes in edema using the person correlation coefficient (this was calculated using data from all time points).
Time Frame	1, 2, 3, and 4 months after injection of a dexamethasone implant or anti-VEGF agent

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexamethasone Implant	Anti-VEGF Agent
Arm/Group Description	Patients received an injection of an dexamethasone implant	Patients received PRN injections of an Anti-VEGF agent
Measure Participants	20	20
IGF-BP1	0.47	0.059
Prolactin	0.45	0.369
MMP-9	0.45	0.29
EG-VEGF	0.43	-0.004
Endostatin	0.41	0.189
Angiopoietin-2	0.40	0.229
IGF-BP3	0.36	0.435
Persephin	0.35	0.114
MIP-1a	0.34	-0.107
THSP-2	0.33	0.064
HGF	0.31	0.226
IL-8	0.30	-0.184
CXCL16	0.29	0.027

Adverse Events

Arm/Group Title	All Participants
Arm/Group Description
All Cause Mortality
	All Participants
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	All Participants
	Affected / at Risk (%)	# Events
Total	4/20 (20%)
Cardiac disorders
Mitral valve repair surgery	1/20 (5%)
Eye disorders
Cataract progression	1/20 (5%)
Endophthalmitis	1/20 (5%)
Nervous system disorders
Emergency room visit because of a possible seizure	1/20 (5%)
Other (Not Including Serious) Adverse Events
	All Participants
	Affected / at Risk (%)	# Events
Total	11/20 (55%)
Blood and lymphatic system disorders
Blood transfusion due to severe anemia	1/20 (5%)
Cardiac disorders
Racing of heart	1/20 (5%)
Eye disorders
Vision loss	1/20 (5%)
Increased Intraocular pressure	1/20 (5%)
Eye soreness	1/20 (5%)
Bruising of eyelid	1/20 (5%)
General disorders
Patient had a fall	2/20 (10%)
Musculoskeletal and connective tissue disorders
Steroid injection in the hip due to arthritis	1/20 (5%)
Foot Infection	1/20 (5%)
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis	1/20 (5%)
Cough	1/20 (5%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.