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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00511706




Registration number
NCT00511706
Ethics application status
Date submitted
2/08/2007
Date registered
6/08/2007
Date last updated
25/04/2019

Titles & IDs
Public title
Safety and Efficacy of a New Treatment as Adjunctive Therapy to Anti-vascular Endothelial Growth Factor (Anti-VEGF) Treatment in Patients With Age-Related Macular Degeneration (AMD)
Scientific title
Secondary ID [1] 0 0
206207-016
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
Blood 0 0 0 0
Haematological diseases
Blood 0 0 0 0
Other blood disorders
Cardiovascular 0 0 0 0
Other cardiovascular diseases

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

Experimental: dexamethasone and ranibizumab - Intravitreal injection of dexamethasone 700 µg at Day 1; ranibizumab 500 µg at Day -30 and Day 7-14.

Sham Comparator: sham and ranibizumab - Sham injection at Day 1; ranibizumab 500 µg at day -30 and Day 7-14.


Treatment: Drugs: dexamethasone
Intravitreal injection of dexamethasone 700 µg at Day 1.

Other interventions: ranibizumab
Ranibizumab 500 µg at day -30 and Day 7-14.

Other interventions: sham
Sham needle-less injection administered in the study eye at Day 1.

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
Injection Free Interval - The injection free interval was defined as the number of days between receiving the second ranibizumab injection (day 7 to 14) to the investigator's determination of eligibility to receive a third ranibizumab injection in the study eye.
Timepoint [1] 0 0
Week 1 to Week 25
Secondary outcome [1] 0 0
Change From Baseline in the Best Corrected Visual Acuity (BCVA) at Week 25 - 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 means that vision has improved.
Timepoint [1] 0 0
Baseline, Week 25
Secondary outcome [2] 0 0
Change From Baseline in the Mean Central Retinal Subfield Thickness at Week 25 as Assessed by Optical Coherence Tomography (OCT) in the Study Eye - Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed in the study eye after pupil dilation at baseline and Month 25.
Timepoint [2] 0 0
Baseline, Week 25
Secondary outcome [3] 0 0
Change From Screening in the Area of Leakage From Choroidal Neovascularization (CNV) at Week 25 as Assessed by Fluorescein Angiography in the Study Eye - 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 was performed on the study eye after dilation at Screening and Week 25.
Timepoint [3] 0 0
Screening (-Week 28), Week 25

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

- Visual Acuity between 20/40 and 20/400 in the study eye
Minimum age
50 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Any intraocular surgery within 3 months

- Glaucoma

- Cataract

- High eye pressure

- Uncontrolled systemic disease

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
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
- Parramatta
Recruitment postcode(s) [1] 0 0
- Parramatta
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
France
State/province [2] 0 0
Paris
Country [3] 0 0
Israel
State/province [3] 0 0
Tel Aviv
Country [4] 0 0
Italy
State/province [4] 0 0
Milano
Country [5] 0 0
Korea, Republic of
State/province [5] 0 0
Seoul
Country [6] 0 0
New Zealand
State/province [6] 0 0
Auckland
Country [7] 0 0
Portugal
State/province [7] 0 0
Coimbra
Country [8] 0 0
United Kingdom
State/province [8] 0 0
Hampshire

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 implant of dexamethasone
with Anti-VEGF treatment vs. Anti-VEGF alone (with sham dexamethasone injection) in patients
with subfoveal choroidal neovascularization secondary to age-related macular degeneration.
Trial website
https://clinicaltrials.gov/show/NCT00511706
Trial related presentations / publications
Kuppermann BD, Goldstein M, Maturi RK, Pollack A, Singer M, Tufail A, Weinberger D, Li XY, Liu CC, Lou J, Whitcup SM; Ozurdex® ERIE Study Group. Dexamethasone Intravitreal Implant as Adjunctive Therapy to Ranibizumab in Neovascular Age-Related Macular Degeneration: A Multicenter Randomized Controlled Trial. Ophthalmologica. 2015;234(1):40-54. doi: 10.1159/000381865. Epub 2015 Jun 18.
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