Brief Summary

This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of diabetic macular edema.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

494

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Feb 2005

Longer than P75 for phase_3

Geographic Reach

10 countries

10 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

7.3 years study duration

Study Start

First participant enrolled

February 1, 2005

Completed

7 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed

3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed

6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed

2.2 years until next milestone

Results Posted

Study results publicly available

August 4, 2014

Completed

Last Updated

August 4, 2014

Status Verified

July 1, 2014

Enrollment Period

7.3 years

First QC Date

September 12, 2005

Results QC Date

July 10, 2014

Last Update Submit

July 10, 2014

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

Percentage of Patients With a Best Corrected Visual Acuity (BCVA) Improvement of ≥15 Letters From Baseline in the Study Eye
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.
Baseline, Month 39/Final Visit

Secondary Outcomes (6)

Average Change From Baseline in BCVA in the Study Eye
Baseline, 39 Months
Change From Baseline in BCVA in the Study Eye
Baseline, Month 39/Final Visit
Percentage of Patients With a BCVA Improvement of ≥10 Letters From Baseline in the Study Eye
Baseline, Month 39/Final Visit
Average Change From Baseline in Retinal Thickness as Measured by Optical Coherence Tomography (OCT)
Baseline, 39 Months
10th Percentile for Time to BCVA Improvement of ≥15 Letters From Baseline in the Study Eye
Baseline, 39 Months
+1 more secondary outcomes

Study Arms (3)

Dexamethasone 700 μg

EXPERIMENTAL

700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.

Drug: Dexamethasone

Dexamethasone 350 μg

EXPERIMENTAL

350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.

Drug: Dexamethasone

Sham

SHAM COMPARATOR

Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.

Other: Sham

Interventions

DexamethasoneDRUG

350 µg or 700 µg dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.

Also known as: Posurdex®, Ozurdex®

Dexamethasone 350 μgDexamethasone 700 μg

ShamOTHER

Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.

Sham

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

years of age or older with diabetic macular edema;
Decrease in visual acuity in at least one eye as a result of macular edema (20/50 or worse);
Visual acuity in other eye no worse than 20/200

You may not qualify if:

Known anticipated need for ocular surgery within first 12 months of study;
History of glaucoma or current high eye pressure requiring more than 1 medication;
Uncontrolled systemic disease;
Known steroid-responder;
Use of systemic steroids
Use of Warfarin/Heparin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Allerganlead

Study Sites (10)

Unknown Facility

Inglewood, California, United States

Location

Unknown Facility

Westmead, New South Wales, Australia

Location

Unknown Facility

Toronto, Ontario, Canada

Location

Unknown Facility

Prague, Czechia

Location

Unknown Facility

Hamburg, Germany

Location

Unknown Facility

Tel Aviv, Israel

Location

Unknown Facility

Rockwell Center, Makati, Philippines

Location

Unknown Facility

Coimbra, Portugal

Location

Unknown Facility

Cape Town, South Africa

Location

Unknown Facility

Barcelona, Spain

Location

Related Publications (6)

Kozak I, Do DV, Lai H, Ogidigben MJ, Lopez FJ. Time-in-Range Analysis of Responses after Intravitreal Dexamethasone Therapy in Eyes with Diabetic Macular Edema. Ophthalmol Sci. 2025 May 26;5(5):100833. doi: 10.1016/j.xops.2025.100833. eCollection 2025 Sep-Oct.
PMID: 40688490DERIVED
Valentim CCS, Lai H, Ogidigben MJ, Singh RP, Talcott KE. Baseline factors affecting diabetic macular oedema resolution after intravitreal dexamethasone implant treatment: post hoc analysis of the MEAD study. BMC Ophthalmol. 2025 Jul 9;25(1):403. doi: 10.1186/s12886-025-04208-3.
PMID: 40634898DERIVED
Rittiphairoj T, Mir TA, Li T, Virgili G. Intravitreal steroids for macular edema in diabetes. Cochrane Database Syst Rev. 2020 Nov 17;11(11):CD005656. doi: 10.1002/14651858.CD005656.pub3.
PMID: 33206392DERIVED
Yoon YH, Boyer DS, Maturi RK, Bandello F, Belfort R Jr, Augustin AJ, Li XY, Bai Z, Hashad Y; Ozurdex MEAD Study Group. Natural history of diabetic macular edema and factors predicting outcomes in sham-treated patients (MEAD study). Graefes Arch Clin Exp Ophthalmol. 2019 Dec;257(12):2639-2653. doi: 10.1007/s00417-019-04464-2. Epub 2019 Oct 25.
PMID: 31654188DERIVED
Danis RP, Sadda S, Li XY, Cui H, Hashad Y, Whitcup SM. Anatomical effects of dexamethasone intravitreal implant in diabetic macular oedema: a pooled analysis of 3-year phase III trials. Br J Ophthalmol. 2016 Jun;100(6):796-801. doi: 10.1136/bjophthalmol-2015-306823. Epub 2015 Nov 18.
PMID: 26581718DERIVED
Augustin AJ, Kuppermann BD, Lanzetta P, Loewenstein A, Li XY, Cui H, Hashad Y, Whitcup SM; Ozurdex MEAD Study Group. Dexamethasone intravitreal implant in previously treated patients with diabetic macular edema: subgroup analysis of the MEAD study. BMC Ophthalmol. 2015 Oct 30;15:150. doi: 10.1186/s12886-015-0148-2.
PMID: 26519345DERIVED

MeSH Terms

Interventions

DexamethasoneCalcium Dobesilatesalicylhydroxamic acid

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedBenzenesulfonatesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsArylsulfonatesArylsulfonic AcidsSulfonic AcidsSulfur AcidsSulfur Compounds

Results Point of Contact

Title: Therapeutic Area Head,
Organization: Allergan, Inc

Study Officials

Medical Director
Allergan
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

February 1, 2005

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

August 4, 2014

Results First Posted

August 4, 2014

Record last verified: 2014-07

Locations

PT(1)IL(1)PH(1)ES(1)US(1)AU(1)CA(1)CZ(1)DE(1)ZA(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (3)

Dexamethasone 700 μg

Dexamethasone 350 μg

Sham

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (10)

Related Publications (6)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations