NCT00799227

Safety and Efficacy of a New Treatment in Vitrectomized Subjects With Diabetic Macular Edema

Completed Phase 2 Results posted Last updated 23 April 2019

What this trial tests

Phase 2 trial testing Dexamethasone in Diabetic Macular Edema in 56 participants. Completed in 1 December 2009.

Timeline

1 January 2009

Primary endpoint
1 December 2009

1 December 2009

Quick facts

Lead sponsor	Allergan
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	56
Start date	1 January 2009
Primary completion	1 December 2009
Estimated completion	1 December 2009
Sites	2 locations across United States, Australia

Drugs / interventions tested

• Dexamethasone (dexamethasone) — full drug profile →

Conditions studied

• Diabetic Macular Edema — all drugs for Diabetic Macular Edema →
• Vitrectomy — all drugs for Vitrectomy →

Sponsor

Allergan — full company profile →

Who can join

18 and older, any sex, with Diabetic Macular Edema or Vitrectomy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline in Central Retinal Thickness in the Study Eye Primary · Baseline, Week 26

Central retinal thickness is assessed in the study eye by Optical Coherence Tomography (OCT). 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 change from baseline in retinal thickness indicates an improvement and a positive change from baseline indicates a worsening.

Baseline

Group	Value	95% CI
700 µg Dexamethasone Implant	403.4	± 117.10

Change from Baseline at Week 26

Group	Value	95% CI
700 µg Dexamethasone Implant	-38.9	± 96.93

Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye Secondary · Baseline, Week 26

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 from baseline in the number of letters read correctly indicates improvement and a decrease from baseline in the number of letters read correctly indicates a worsening.

Baseline

Group	Value	95% CI
700 µg Dexamethasone Implant	54.5	± 12.60

Change from Baseline at Week 26

Group	Value	95% CI
700 µg Dexamethasone Implant	3.0	± 11.11

Percentage of Patients With at Least 10 Letters of Improvement in BCVA From Baseline in the Study Eye Secondary · Baseline, Week 26

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.

Group	Value	95% CI
700 µg Dexamethasone Implant	21.4

Percentage of Patients With Fluorescein Leakage as Measured by Fluorescein Angiography (FA) in the Study Eye Secondary · Baseline, Week 26

Fluorescein leakage is measured in the study eye by FA. FA is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. The assessment of fluorescein leakage compared to baseline is categorized as Improved (leakage area decreased ≥ 10%), Unchanged (leakage area changed \< 10%), and Worsened (leakage area increased ≥ 10%).

Improved at Week 26

Group	Value	95% CI
700 µg Dexamethasone Implant	33.3

Unchanged at Week 26

Group	Value	95% CI
700 µg Dexamethasone Implant	57.1

Worsened at Week 26

Group	Value	95% CI
700 µg Dexamethasone Implant	9.5

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

700 µg Dexamethasone Implant

Serious: 14/55 (25%)

Deaths: —

Serious adverse events (16 terms)

Reaction	System	700 µg Dexamethasone Implant
Cardiac Failure Congestive	Cardiac disorders	—
Anoxic Encephalopathy	Nervous system disorders	—
Arteriovenous Fistula Thrombosis	Injury, poisoning and procedural complications	—
Atrioventricular Block Second Degree	Cardiac disorders	—
Carotid Artery Stenosis	Nervous system disorders	—
Cholecystitis Acute	Hepatobiliary disorders	—
Diabetic Foot Infection	Infections and infestations	—
Hyperglycaemia	Metabolism and nutrition disorders	—
Ketoacidosis	Metabolism and nutrition disorders	—
Osteomyelitis	Infections and infestations	—
Pancreatitis	Gastrointestinal disorders	—
Pneumonia	Infections and infestations	—
Presyncope	Nervous system disorders	—
Renal Failure	Renal and urinary disorders	—
Soft Tissue Infection	Infections and infestations	—
Transient Ischaemic Attack	Nervous system disorders	—

Other adverse events (12 terms — click to expand)

Reaction	System	700 µg Dexamethasone Implant
Conjunctival Haemorrhage	Eye disorders	—
Conjunctival Hyperaemia	Eye disorders	—
Intraocular Pressure Increased	Investigations	—
Eye Pain	Eye disorders	—
Vitreous Haemorrhage	Eye disorders	—
Conjunctival Oedema	Eye disorders	—
Maculopathy	Eye disorders	—
Renal Failure	Renal and urinary disorders	—
Anterior Chamber Cell	Eye disorders	—
Foreign Body Sensation in Eyes	Eye disorders	—
Iritis	Eye disorders	—
Myodesopsia	Eye disorders	—

Most-reported serious reactions: Cardiac Failure Congestive, Anoxic Encephalopathy, Arteriovenous Fistula Thrombosis, Atrioventricular Block Second Degree, Carotid Artery Stenosis, Cholecystitis Acute, Diabetic Foot Infection, Hyperglycaemia.

Data from ClinicalTrials.gov NCT00799227 adverse events section.

Sponsor's own description

The study will evaluate the safety and efficacy of the intravitreal dexamethasone implant in the study eye of vitrectomized subjects with diabetic macular edema. Subjects will be followed for 26 weeks.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.