Trial Outcomes & Findings for Safety and Efficacy of a New Treatment in Vitrectomized Subjects With Diabetic Macular Edema (NCT NCT00799227)
NCT ID: NCT00799227
Last Updated: 2019-04-23
Results Overview
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.
COMPLETED
PHASE2
56 participants
Baseline, Week 26
2019-04-23
Participant Flow
Participant milestones
| Measure |
700 µg Dexamethasone Implant
700 µg dexamethasone implant in the study eye at Day 1
|
|---|---|
|
Overall Study
STARTED
|
56
|
|
Overall Study
COMPLETED
|
53
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of a New Treatment in Vitrectomized Subjects With Diabetic Macular Edema
Baseline characteristics by cohort
| Measure |
700 µg Dexamethasone Implant
n=56 Participants
700 µg dexamethasone implant in the study eye at Day 1
|
|---|---|
|
Age, Customized
18 to 65 years
|
37 Participants
n=5 Participants
|
|
Age, Customized
>65 years
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 26Population: Intent to Treat: all enrolled patients
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.
Outcome measures
| Measure |
700 µg Dexamethasone Implant
n=56 Participants
700 µg dexamethasone implant in the study eye at Day 1
|
|---|---|
|
Change From Baseline in Central Retinal Thickness in the Study Eye
Baseline
|
403.4 Microns
Standard Deviation 117.10
|
|
Change From Baseline in Central Retinal Thickness in the Study Eye
Change from Baseline at Week 26
|
-38.9 Microns
Standard Deviation 96.93
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: Intent to Treat: all enrolled patients
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.
Outcome measures
| Measure |
700 µg Dexamethasone Implant
n=56 Participants
700 µg dexamethasone implant in the study eye at Day 1
|
|---|---|
|
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
Baseline
|
54.5 Letters Read Correctly
Standard Deviation 12.60
|
|
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
Change from Baseline at Week 26
|
3.0 Letters Read Correctly
Standard Deviation 11.11
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: Intent to treat: all enrolled patients
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.
Outcome measures
| Measure |
700 µg Dexamethasone Implant
n=56 Participants
700 µg dexamethasone implant in the study eye at Day 1
|
|---|---|
|
Percentage of Patients With at Least 10 Letters of Improvement in BCVA From Baseline in the Study Eye
|
21.4 Percentage of Patients
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: Intent to Treat: all enrolled patients
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%).
Outcome measures
| Measure |
700 µg Dexamethasone Implant
n=56 Participants
700 µg dexamethasone implant in the study eye at Day 1
|
|---|---|
|
Percentage of Patients With Fluorescein Leakage as Measured by Fluorescein Angiography (FA) in the Study Eye
Improved at Week 26
|
33.3 Percentage of Patients
|
|
Percentage of Patients With Fluorescein Leakage as Measured by Fluorescein Angiography (FA) in the Study Eye
Unchanged at Week 26
|
57.1 Percentage of Patients
|
|
Percentage of Patients With Fluorescein Leakage as Measured by Fluorescein Angiography (FA) in the Study Eye
Worsened at Week 26
|
9.5 Percentage of Patients
|
Adverse Events
700 µg Dexamethasone Implant
Serious adverse events
| Measure |
700 µg Dexamethasone Implant
n=55 participants at risk
700 µg dexamethasone implant in the study eye at Day 1
|
|---|---|
|
Cardiac disorders
Cardiac Failure Congestive
|
3.6%
2/55
The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs), and included all treated patients.
|
|
Nervous system disorders
Anoxic Encephalopathy
|
1.8%
1/55
The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs), and included all treated patients.
|
|
Injury, poisoning and procedural complications
Arteriovenous Fistula Thrombosis
|
1.8%
1/55
The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs), and included all treated patients.
|
|
Cardiac disorders
Atrioventricular Block Second Degree
|
1.8%
1/55
The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs), and included all treated patients.
|
|
Nervous system disorders
Carotid Artery Stenosis
|
1.8%
1/55
The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs), and included all treated patients.
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
1.8%
1/55
The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs), and included all treated patients.
|
|
Infections and infestations
Diabetic Foot Infection
|
1.8%
1/55
The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs), and included all treated patients.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.8%
1/55
The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs), and included all treated patients.
|
|
Metabolism and nutrition disorders
Ketoacidosis
|
1.8%
1/55
The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs), and included all treated patients.
|
|
Infections and infestations
Osteomyelitis
|
1.8%
1/55
The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs), and included all treated patients.
|
|
Gastrointestinal disorders
Pancreatitis
|
1.8%
1/55
The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs), and included all treated patients.
|
|
Infections and infestations
Pneumonia
|
1.8%
1/55
The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs), and included all treated patients.
|
|
Nervous system disorders
Presyncope
|
1.8%
1/55
The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs), and included all treated patients.
|
|
Renal and urinary disorders
Renal Failure
|
1.8%
1/55
The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs), and included all treated patients.
|
|
Infections and infestations
Soft Tissue Infection
|
1.8%
1/55
The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs), and included all treated patients.
|
|
Nervous system disorders
Transient Ischaemic Attack
|
1.8%
1/55
The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs), and included all treated patients.
|
Other adverse events
| Measure |
700 µg Dexamethasone Implant
n=55 participants at risk
700 µg dexamethasone implant in the study eye at Day 1
|
|---|---|
|
Eye disorders
Conjunctival Haemorrhage
|
52.7%
29/55
The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs), and included all treated patients.
|
|
Eye disorders
Conjunctival Hyperaemia
|
20.0%
11/55
The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs), and included all treated patients.
|
|
Eye disorders
Eye Pain
|
16.4%
9/55
The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs), and included all treated patients.
|
|
Eye disorders
Vitreous Haemorrhage
|
14.5%
8/55
The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs), and included all treated patients.
|
|
Eye disorders
Conjunctival Oedema
|
12.7%
7/55
The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs), and included all treated patients.
|
|
Eye disorders
Maculopathy
|
10.9%
6/55
The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs), and included all treated patients.
|
|
Eye disorders
Anterior Chamber Cell
|
5.5%
3/55
The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs), and included all treated patients.
|
|
Eye disorders
Foreign Body Sensation in Eyes
|
5.5%
3/55
The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs), and included all treated patients.
|
|
Eye disorders
Iritis
|
5.5%
3/55
The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs), and included all treated patients.
|
|
Eye disorders
Myodesopsia
|
5.5%
3/55
The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs), and included all treated patients.
|
|
Investigations
Intraocular Pressure Increased
|
18.2%
10/55
The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs), and included all treated patients.
|
|
Renal and urinary disorders
Renal Failure
|
7.3%
4/55
The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs), and included all treated patients.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER