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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00775411




Registration number
NCT00775411
Ethics application status
Date submitted
16/10/2008
Date registered
20/10/2008
Date last updated
3/09/2012

Titles & IDs
Public title
Safety and Efficacy of a New Therapy as Adjunctive Therapy to Anti-vascular Endothelial Growth Factor (Anti-VEGF) in Subjects With Wet Age-Related Macular Degeneration (AMD)
Scientific title
Secondary ID [1] 0 0
206207-019
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Choroidal Neovascularization 0 0
Age-Related Maculopathy 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Blood 0 0 0 0
Haematological diseases
Blood 0 0 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - dexamethasone
Other interventions - ranibizumab

Experimental: 700 µg dexamethasone and ranibizumab - 700 µg dexamethasone intravitreal injection at Day 1 in the study eye. Ranibizumab injection at Week 2 or 3 per specified criteria and starting at Week 4 at the investigator's discretion in the study eye.


Treatment: Drugs: dexamethasone
700 µg dexamethasone intravitreal injection at Day 1 in the study eye.

Other interventions: ranibizumab
Ranibizumab injection at Week 2 or 3 per specified criteria and starting at Week 4 at the investigator's discretion in the study eye.

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT) at Week 4 - Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed on the study eye after pupil dilation at baseline and Week 4.
Timepoint [1] 0 0
Baseline, Week 4
Secondary outcome [1] 0 0
Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 26 - BCVA is measured 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 means that vision has improved.
Timepoint [1] 0 0
Baseline, Week 26
Secondary outcome [2] 0 0
Percentage of Participants With Fluorescein Leakage Improved, Unchanged and Worsened From Baseline as Assessed by Fluorescein Angiography at Week 26 - Fluorescein angiography (FA) is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. Photographs are taken with a specialized low-power microscope with an attached camera designed to photograph the interior of the eye, including the retina and optic disc. FA at Week 26 was compared to FA at Baseline. The percentage of participants in each of the following categories is reported: Improved (Leakage area decreased >=10%), Unchanged (Leakage area changed < 10%) and Worsened (Leakage area increased >=10%).
Timepoint [2] 0 0
Baseline, Week 26

Eligibility
Key inclusion criteria
- 50 years of age or older with active subfoveal choroidal neovascularization (CNV)
secondary to AMD

- Central retinal thickness = 300 µm

- Visual acuity between 20/400 and 20/32

- Eligible for Anti-VEGF therapy
Minimum age
50 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Previous treatment for CNV due to AMD

- High eye pressure

- Glaucoma

- Uncontrolled systemic disease

- Known allergy to the study medications

- Recent eye surgery or injections in the eye

- Female subjects that are of childbearing potential

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
- Sydney
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Texas
Country [2] 0 0
Philippines
State/province [2] 0 0
Manila

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Allergan
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The study will evaluate the safety and efficacy of the intravitreal dexamethasone implant as
adjunctive therapy to Anti-VEGF treatment in the study eye of treatment naïve subjects with
choroidal neovascularization secondary to age-related macular degeneration. Subjects will be
followed for 26 weeks.
Trial website
https://clinicaltrials.gov/show/NCT00775411
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Allergan
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications