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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02130024




Registration number
NCT02130024
Ethics application status
Date submitted
27/03/2014
Date registered
2/05/2014
Date last updated
5/06/2019

Titles & IDs
Public title
A Comparison of Ranibizumab and Aflibercept for the Development of Geographic Atrophy in (Wet) AMD Patients
Scientific title
Development of New Geographic Atrophy in Patients With Neovascular (Wet) Age-related Macular Degeneration: a Comparison of Ranibizumab and Aflibercept
Secondary ID [1] 0 0
CRFB002AAU17
Universal Trial Number (UTN)
Trial acronym
RIVAL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Age-Related Macular Degeneration 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ranibizumab 0.5 mg
Treatment: Drugs - Aflibercept 2.0 mg

Experimental: Ranibizumab 0.5 mg - 3 monthly loading doses (Baseline, Week 4, and Week 8), followed by an individualised treatment and evaluation regimen according to disease activity \[treat and extend\]

Active comparator: Aflibercept 2.0 mg - 3 monthly loading doses (Baseline, Week 4, and Week 8), followed by an individualised treatment and evaluation regimen according to disease activity \[treat and extend\]


Treatment: Drugs: Ranibizumab 0.5 mg
Administered as an intravitreal injection

Treatment: Drugs: Aflibercept 2.0 mg
Administered as an intravitreal injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean Change in Square-root Area of Geographic Atrophy (GA) From Baseline to Month 24
Timepoint [1] 0 0
Baseline, Month 24
Secondary outcome [1] 0 0
Mean Change in Square-root Area of Geographic Atrophy From Baseline to Month 12
Timepoint [1] 0 0
Baseline, Month 12
Secondary outcome [2] 0 0
Percentage of Patients With Newly Developed Geographic Atrophy During the Overall 24 Months of the Study
Timepoint [2] 0 0
Baseline, Month 12, Month 24
Secondary outcome [3] 0 0
Mean Number of Intravitreal Injections From Baseline to Month 12 and to Month 24
Timepoint [3] 0 0
Baseline, Month 12, Month 24
Secondary outcome [4] 0 0
Mean Change in Best Corrected Visual Acuity (BCVA) From Baseline to Month 12 and to Month 24
Timepoint [4] 0 0
Baseline, Month 12, Month 24
Secondary outcome [5] 0 0
Mean Change in Central Subfield Foveal Thickness (CSFT) From Baseline to Month 12 and to Month 24
Timepoint [5] 0 0
Baseline, Month 12, Month 24
Secondary outcome [6] 0 0
Percentage of Patients Showing no Intraretinal Fluid (IRF)/Subretinal Fluid (SRF)
Timepoint [6] 0 0
Month 2, Month 12, Month 24
Secondary outcome [7] 0 0
Percentage of Patients Showing Greater Than and Equal to 15 Letters Gain for BCVA From Baseline to Month 12 and to Month 24
Timepoint [7] 0 0
Baseline, Month 12, Month 24
Secondary outcome [8] 0 0
Percentage of Patients Showing Less Than and Equal to 15 Letters Loss for BCVA From Baseline to Month 12 and to Month 24
Timepoint [8] 0 0
Baseline, Month 12, Month 24
Secondary outcome [9] 0 0
Mean Number of Times a Patient Needed to Return to Monthly Intravitreal Injections Over 24 Months
Timepoint [9] 0 0
Month 24
Secondary outcome [10] 0 0
Mean Change in Vascular Endothelial Growth Factor (VEGF) Plasma Concentration From Baseline to 7 Days After the Second and 7 Days After the Third Mandated Intravitreal Injection of Treatment
Timepoint [10] 0 0
Baseline, Week 5, Week 9
Secondary outcome [11] 0 0
Percentage of Patients With Change in Retinal Nerve Fibre Thickness From Baseline to Month 12 and Month 24
Timepoint [11] 0 0
Baseline, Month 12, Month 24
Secondary outcome [12] 0 0
Percentage of Patients With Ocular Inflammation at Baseline and 7 Days Post-injection Following 3rd Mandated Intravitreal Injection - Anterior Chamber Cells
Timepoint [12] 0 0
Baseline, Week 9
Secondary outcome [13] 0 0
Percentage of Patients With Ocular Inflammation at Baseline and 7 Days Post-injection Following 3rd Mandated Intravitreal Injection - Anterior Chamber Flare
Timepoint [13] 0 0
Baseline, Week 9

Eligibility
Key inclusion criteria
Inclusion criteria:

- Written informed consent.

Inclusion criteria specific to the study eye:

* Diagnosis of active subfoveal Choroidal Neovascularisation (CNV) secondary to wet Age-related Macular Degeneration (AMD);
* Best Corrected Visual Acuity (BCVA) score of 23 letters or more as measured by 3-metre Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

* Pregnant, nursing, or at risk of becoming pregnant during the study;
* Inability to comply with the study or follow-up procedures;
* Recent (3 months) stroke or myocardial infarction; uncontrolled hypertension; hypersensitivity to the study treatments or to fluorescein;
* In either eye: active periocular or ocular infection or inflammation; iris neovascularisation; uncontrolled or neovascular glaucoma; or one or more patch of geographic atrophy (GA) as specified in the protocol.

Exclusion criteria specific to the study eye:

* Prior or current treatment with anti-angiogenic drugs or corticosteroids;
* Other eye conditions as specified in the protocol;
* Any intraocular procedure carried out within 2 months before baseline or anticipated within 6 months following baseline.

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


Intervention assignment
Parallel
Other design features
Phase
Phase 4
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
11/04/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/11/2017
Sample size
Target
Accrual to date
Final
281
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Novartis Investigative Site - Albury
Recruitment hospital [2] 0 0
Novartis Investigative Site - Brookvale
Recruitment hospital [3] 0 0
Novartis Investigative Site - Chatswood
Recruitment hospital [4] 0 0
Novartis Investigative Site - Hurtsville
Recruitment hospital [5] 0 0
Novartis Investigative Site - Mona Vale
Recruitment hospital [6] 0 0
Novartis Investigative Site - Parramatta
Recruitment hospital [7] 0 0
Novartis Investigative Site - Strathfield
Recruitment hospital [8] 0 0
Novartis Investigative Site - Sydney
Recruitment hospital [9] 0 0
Novartis Investigative Site - Westmead
Recruitment hospital [10] 0 0
Novartis Investigative Site - Caboolture
Recruitment hospital [11] 0 0
Novartis Investigative Site - Redcliffe
Recruitment hospital [12] 0 0
Novartis Investigative Site - South Brisbane
Recruitment hospital [13] 0 0
Novartis Investigative Site - Southport
Recruitment hospital [14] 0 0
Novartis Investigative Site - Adelaide
Recruitment hospital [15] 0 0
Novartis Investigative Site - South Launceston
Recruitment hospital [16] 0 0
Novartis Investigative Site - Clayton
Recruitment hospital [17] 0 0
Novartis Investigative Site - Malvern
Recruitment hospital [18] 0 0
Novartis Investigative Site - Parkville,
Recruitment hospital [19] 0 0
Novartis Investigative Site - Nedlands
Recruitment hospital [20] 0 0
Novartis Investigative Site - Subiaco
Recruitment postcode(s) [1] 0 0
2640 - Albury
Recruitment postcode(s) [2] 0 0
2100 - Brookvale
Recruitment postcode(s) [3] 0 0
2067 - Chatswood
Recruitment postcode(s) [4] 0 0
2220 - Hurtsville
Recruitment postcode(s) [5] 0 0
- Mona Vale
Recruitment postcode(s) [6] 0 0
2150 - Parramatta
Recruitment postcode(s) [7] 0 0
2035 - Strathfield
Recruitment postcode(s) [8] 0 0
2135 - Strathfield
Recruitment postcode(s) [9] 0 0
2000 - Sydney
Recruitment postcode(s) [10] 0 0
AUSTRALIA - Sydney
Recruitment postcode(s) [11] 0 0
2145 - Westmead
Recruitment postcode(s) [12] 0 0
4510 - Caboolture
Recruitment postcode(s) [13] 0 0
4020 - Redcliffe
Recruitment postcode(s) [14] 0 0
4101 - South Brisbane
Recruitment postcode(s) [15] 0 0
4215 - Southport
Recruitment postcode(s) [16] 0 0
5000 - Adelaide
Recruitment postcode(s) [17] 0 0
7249 - South Launceston
Recruitment postcode(s) [18] 0 0
3168 - Clayton
Recruitment postcode(s) [19] 0 0
3144 - Malvern
Recruitment postcode(s) [20] 0 0
3065 - Parkville,
Recruitment postcode(s) [21] 0 0
6009 - Nedlands
Recruitment postcode(s) [22] 0 0
6008 - Subiaco

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study was to compare the development of new geographic atrophy in patients with wet Age-related Macular Degeneration (AMD) when treated with either ranibizumab or aflibercept over 24 months. Geographic atrophy is an advanced form of AMD that can result in the progressive and irreversible loss of visual function over time.
Trial website
https://clinicaltrials.gov/study/NCT02130024
Trial related presentations / publications
Li E, Donati S, Lindsley KB, Krzystolik MG, Virgili G. Treatment regimens for administration of anti-vascular endothelial growth factor agents for neovascular age-related macular degeneration. Cochrane Database Syst Rev. 2020 May 5;5(5):CD012208. doi: 10.1002/14651858.CD012208.pub2.
Gillies MC, Hunyor AP, Arnold JJ, Guymer RH, Wolf S, Ng P, Pecheur FL, McAllister IL. Effect of Ranibizumab and Aflibercept on Best-Corrected Visual Acuity in Treat-and-Extend for Neovascular Age-Related Macular Degeneration: A Randomized Clinical Trial. JAMA Ophthalmol. 2019 Apr 1;137(4):372-379. doi: 10.1001/jamaophthalmol.2018.6776.
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
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/NCT02130024