Safety and Efficacy of a New Treatment in Combination With Laser for Diabetic Macular Edema

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00464685

Enrollment

253

Registered

2007-04-24

Start date

2007-05-01

Completion date

2010-02-08

Last updated

2019-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Macular Edema

Brief summary

This study will evaluate the safety and efficacy of the intravitreal implant of dexamethasone with laser treatment vs. laser treatment alone in patients with diabetic macular edema.

Interventions

DRUGDexamethasone

Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria.

DRUGSham injection

Initial sham injection with up to 1 additional treatment based on re-treatment criteria.

PROCEDURELaser Photocoagulation

Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 18 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

Exclusion criteria

* Known anticipated need for ocular surgery within next 12 months * 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

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Patients With at Least 10 Letters of Improvement in Best Corrected Visual Acuity (BCVA) From Baseline in the Study Eye	Baseline, Month 12	BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). 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.

Secondary

Measure	Time frame	Description
Change From Baseline in BCVA in the Study Eye	Baseline, Month 12	BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). 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.
Time to Retreatment in the Study Eye	12 Months	Time to retreatment in the study eye is defined as the number of days between the initial treatment and re-treatment with the study medication.
Change From Baseline in Central Subfield Retinal Thickness in the Study Eye	Baseline, Month 12	Central subfield retinal thickness is assessed in the study eye by Optical Coherence Tomography (OCT). The central subfield is an area in the retina (back of the eye). OCT is a laser-based, noninvasive, diagnostic system that provides high-resolution, three-dimensional images of the retina from which retinal thickness can be measured. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.
Change From Baseline in the Focal Leakage Area in the Study Eye	Baseline, Month 12	Focal leakage area in the study eye is assessed using fluorescein angiography. A positive number change from baseline indicates a worsening and a negative number change from baseline indicates an improvement.

Countries

Canada, United States

Participant flow

Participants by arm

Arm	Count
700 µg Dexamethasone Implant and Laser Photocoagulation Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.	126
Sham Implant and Laser Photocoagulation Initial sham injection with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.	127
Total	253

Baseline characteristics

Characteristic	700 µg Dexamethasone Implant and Laser Photocoagulation	Sham Implant and Laser Photocoagulation	Total
Age, Customized 45 to 65 years	72 Participants	84 Participants	156 Participants
Age, Customized <45 years	7 Participants	3 Participants	10 Participants
Age, Customized >65 years	47 Participants	40 Participants	87 Participants
Sex: Female, Male Female	64 Participants	61 Participants	125 Participants
Sex: Female, Male Male	62 Participants	66 Participants	128 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	125 / 125	127 / 127
serious Total, serious adverse events	23 / 125	27 / 127

Outcome results

Primary

Percentage of Patients With at Least 10 Letters of Improvement in Best Corrected Visual Acuity (BCVA) From Baseline in the Study Eye

BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). 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.

Time frame: Baseline, Month 12