Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000223336
Ethics application status
Approved
Date submitted
23/04/2008
Date registered
28/04/2008
Date last updated
12/12/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Prognostic factors affecting outcome of vascular growth factor inhibitor bevacizumab (Avastin) therapy and reactivation of the disease in the wet age related degeneration of the eye.
Scientific title
The effect of anterior chamber protein concentration, gene polymorphisms and complement factors on visual acuity, contrast sensitivity, microperimetry, optical coherence tomography (OCT) findings and need of repeated drug injections in patients with exudative age related macular degeneration treated with intravitreal bevacizumab (Avastin) injection therapy.
Secondary ID [1] 283171 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Age related macular degeneration of the eye (AMD) 3091 0
Condition category
Condition code
Eye 3248 3248 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Bevacizumab 25 mg/ml, Avastin, Roche, 0,05 ml, 1,25 mg injected intravitreally once a month for two years when exudative AMD lesion is diagnosed to be active.
Intervention code [1] 2831 0
Treatment: Drugs
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 4131 0
Visual acuity tested with charts used in Early Treatment Diabetic Retinopathy Study (ETDRS Charts)
Timepoint [1] 4131 0
At baseline and at 1, 2, 3 and 4 weeks, then monthly for 2 years
Primary outcome [2] 4132 0
Retinal thickness measured with Oti Spectral optical coherence tomography/scanning laser ophthalmoscope (OCT/SLO)
Timepoint [2] 4132 0
At baseline and at 1, 2, 3 and 4 weeks, then monthly for 2 years
Primary outcome [3] 4133 0
Total number of drug injections needed to treat the exudative AMD lesion
Timepoint [3] 4133 0
At 2 years
Secondary outcome [1] 6963 0
Central macular sensitivity tested with Oti Spectral optical coherence tomography/scanning laser ophthalmoscope (OCT/SLO) microperimetry
Timepoint [1] 6963 0
At baseline and at 1, 2, 3 and 4 weeks, then monthly for 2 years
Secondary outcome [2] 6964 0
Contrast sensitivity tested with Pelli-Robson Contrast Sensitivity Charts
Timepoint [2] 6964 0
At baseline and at 1, 2, 3 and 4 weeks, then monthly for 2 years
Secondary outcome [3] 319362 0
Anterior chamber flare levels measured with Kowa Laser Flare Meter FM-500, Kowa Company Ltd., Nagoya, Japan
Timepoint [3] 319362 0
At baseline and at 1, 2, 3 and 4 weeks, then monthly for 2 years
Secondary outcome [4] 319363 0
Microperimetry results, measured with the spectral domain OCT/scanning laser ophthalmoscope, Spectral OCT/SLO, Opko/OTI, Miami, FL, USA.
Timepoint [4] 319363 0
At baseline and at 1, 2, 3 and 4 weeks, then monthly for 2 years

Eligibility
Key inclusion criteria
Patients with classic, predominantly classic, minimally classic or occult type of exudative AMD and visual acuity at least 20/200.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Prior treatment of exudative macular degeneration, prior intraocular surgery other than uncomplicated cataract surgery, uncomplicated cataract surgery within one year, diabetes, intraocular tumors, other retinal diseases or retinal vascular occlusions, prior retinal panphotocoagulation, prior significant intraocular inflammation or infection and poor co-operation.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/05/2008
Actual
7/05/2008
Date of last participant enrolment
Anticipated
Actual
30/04/2010
Date of last data collection
Anticipated
Actual
4/04/2012
Sample size
Target
60
Accrual to date
Final
50
Recruitment outside Australia
Country [1] 954 0
Finland
State/province [1] 954 0
Helsingin ja Uudenmaan sairaanhoitopiiri

Funding & Sponsors
Funding source category [1] 3340 0
Hospital
Name [1] 3340 0
Helsinki University Central Hospital Research Foundation
Country [1] 3340 0
Finland
Primary sponsor type
Individual
Name
Ilkka Immonen
Address
HYKS Silmaklinikka
PL 220
00029 HUS
Country
Finland
Secondary sponsor category [1] 2985 0
Individual
Name [1] 2985 0
Asta Hautamaki
Address [1] 2985 0
HYKS Silmaklinikka
PL 220
00029 HUS
Country [1] 2985 0
Finland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5364 0
NKL NSK:n eettinen toimikunta
Ethics committee address [1] 5364 0
HYKS, NKL NSK eettinen tmk
PL 220
00029 HUS
Ethics committee country [1] 5364 0
Finland
Date submitted for ethics approval [1] 5364 0
Approval date [1] 5364 0
10/01/2008
Ethics approval number [1] 5364 0
Dnro 387/E9/07 HUS

Summary
Brief summary
The purpose of the study is to find factors that may affect the efficacy of the intraocular vascular growth factor inhibitor treatment in patients with the wet form of age related degeneration of the eye. Factors studied are specific genetic markers, proteins involved in immune response and protein concentration in the anterior chamber of the eye.
Trial website
Trial related presentations / publications
Publications:

Hautamäki A, Luoma A, Immonen I. Anterior Chamber Flare during Bevacizumab Treatment in Eyes with Exudative Age-Related Macular Degeneration. Retina 2016;36:2183-2190.

Hautamäki A, Seitsonen S, Holopainen J, Moilanen J, Kivioja J, Onkamo P, Järvelä I, Immonen I. The genetic variant rs4073 A/T of the Interleukin-8 promoter region is associated with the earlier onset of exudative age-related macular degeneration. Acta Ophthalmologica 2015;93(8):726-733.

Hautamäki, A., Kivioja, J., Seitsonen, S., Savolainen, E-R., Liinamaa, MJ., Luoma, A., Järvelä, I., Immonen, I. The IL-8, VEGF, and CFH Polymorphisms and Bevacizumab in Age-related Macular Degeneration. Ophthalmology 2014;121(4):973-973.

Hautamäki, A., Oikkonen, J., Onkamo, P., Immonen, I. Correlation between components of newly diagnosed exudative age-related macular degeneration lesion and focal retinal sensitivity. Acta Ophthalmologica, 2014;92(1):51-58.

Hautamäki, A., Kivioja, J., Vavuli, S., Kakko, S., Savolainen, E-R., Savolainen, MJ., Liinamaa, MJ., Seitsonen, S., Onkamo, P., Järvelä, I., Immonen, I. Interleukin-8 promoter polymorphism predicts the initial response to bevacizumab treatment for exudative age-related macular degeneration. Retina 2013;33(9):1815-1827.


Presentations:

Immonen, IJ., Hautamäki, A. Anterior chamber flare during a prospective 2-year study of pro re nata (PRN) treatment of exudative age-related macular degeneration (AMD) with intravitreal bevacizumab injections. Poster presentation, ARVO 2015, Annual meeting of the Association for Research in Vision and Ophthalmology, Denver, CO, USA.

Hautamäki, A., Kivioja, J., Vavuli, S., Kakko, S., Savolainen, E-R., Savolainen, MJ., Liinamaa, MJ., Seitsonen, S., Onkamo, P., Järvelä, I., Luoma, A., Immonen, I. The effects of interleukin-8, VEGF and CFH polymorphisms on the long-term response to bevacizumab therapy in exudative age-related macular degeneration. Oral presentation, EVER 2013, Congress of the European Association for Vision and Eye Research, Nice, France.

Immonen, I., Hautamäki, A., Kivioja, J., Vavuli, S., Kakko, S., Savolainen, E-R., Savolainen, MJ., Liinamaa, MJ., Seitsonen, S., Onkamo, P., Järvelä, I. Interleukin-8 promoter polymorphism is associated with the initial repose to bevacizumab in AMD treatment. Poster presentation, EVER 2013, Congress of the European Association for Vision and Eye Research, Nice, France.

Hautamäki, A., Kivioja, J., Vavuli, S., Kakko, S., Savolainen, E-R., Savolainen, MJ., Liinamaa, MJ., Seitsonen, S., Onkamo, P., Järvelä, I., Immonen, I. The association of IL-8 promoter polymorphism -251 A/T to the initial bevacizumab treatment response in exudative AMD. Oral presentation, Euretina 2013, Congress of the European Society of Retina Specialists, Hamburg, Germany.

Immonen, IJ., Hautamäki, A., Oikkonen, J., Onkamo, P. Correlation Between Components Of Newly Diagnosed Exudative Age-related Macular Degeneration Lesion And Focal Retinal Sensitivity In Oct-microperimetry. Poster presentation, ARVO 2012, Annual meeting of the Association for Research in Vision and Ophthalmology, Fort Lauderdale, FL, USA.

Hautamäki, A., Immonen, I. Correlation between components of exudative age-related macular degeneration lesion and local retinal sensitivity. Poster presentation, NOK 2010, Nordic Congress of Ophthalmology, Reykjavik, Iceland.
Public notes

Contacts
Principal investigator
Name 28553 0
Dr Asta Hautamaki
Address 28553 0
HYKS Silmaklinikka
PL 220
00029 HUS
Finland
Country 28553 0
Finland
Phone 28553 0
+358 40 82 22 911
Fax 28553 0
Email 28553 0
[email protected]
Contact person for public queries
Name 11710 0
Dr Asta Hautamaki
Address 11710 0
HYKS Silmaklinikka
PL 220
00029 HUS
Country 11710 0
Finland
Phone 11710 0
+358 50 427 93 13
Fax 11710 0
Email 11710 0
[email protected]
Contact person for scientific queries
Name 2638 0
Prof Ilkka Immonen
Address 2638 0
HYKS Silmaklinikka
PL 220
00029 HUS
Country 2638 0
Finland
Phone 2638 0
+358 9 471 73 167
Fax 2638 0
Email 2638 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseANTERIOR CHAMBER FLARE during BEVACIZUMAB TREATMENT in EYES with EXUDATIVE AGE-RELATED MACULAR DEGENERATION.2016https://dx.doi.org/10.1097/IAE.0000000000001061
N.B. These documents automatically identified may not have been verified by the study sponsor.