Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Treatment: Other - 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.

Treatment: Other: 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
Treatment: Other
Intervention code [3] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Injection Free Interval
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
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
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
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
Sex
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
1/11/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2009
Sample size
Target
Accrual to date
Final
243
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/study/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(R) 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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00511706