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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]

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)

Condition category

Condition code

Eye

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]

Treatment: Drugs

Comparator / control treatment

Uncontrolled

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Visual acuity tested with charts used in Early Treatment Diabetic Retinopathy Study (ETDRS Charts)

Timepoint [1]

At baseline and at 1, 2, 3 and 4 weeks, then monthly for 2 years

Primary outcome [2]

Retinal thickness measured with Oti Spectral optical coherence tomography/scanning laser ophthalmoscope (OCT/SLO)

Timepoint [2]

At baseline and at 1, 2, 3 and 4 weeks, then monthly for 2 years

Primary outcome [3]

Total number of drug injections needed to treat the exudative AMD lesion

Timepoint [3]

At 2 years

Secondary outcome [1]

Central macular sensitivity tested with Oti Spectral optical coherence tomography/scanning laser ophthalmoscope (OCT/SLO) microperimetry

Timepoint [1]

At baseline and at 1, 2, 3 and 4 weeks, then monthly for 2 years

Secondary outcome [2]

Contrast sensitivity tested with Pelli-Robson Contrast Sensitivity Charts

Timepoint [2]

At baseline and at 1, 2, 3 and 4 weeks, then monthly for 2 years

Secondary outcome [3]

Anterior chamber flare levels measured with Kowa Laser Flare Meter FM-500, Kowa Company Ltd., Nagoya, Japan

Timepoint [3]

At baseline and at 1, 2, 3 and 4 weeks, then monthly for 2 years

Secondary outcome [4]

Microperimetry results, measured with the spectral domain OCT/scanning laser ophthalmoscope, Spectral OCT/SLO, Opko/OTI, Miami, FL, USA.

Timepoint [4]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Finland

State/province [1]

Helsingin ja Uudenmaan sairaanhoitopiiri

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Helsinki University Central Hospital Research Foundation

Address [1]

HUS yhtymahallinto
Tutkimus- ja opetusryhma
PL 100
00029 HUS

Country [1]

Finland

Primary sponsor type

Individual

Name

Ilkka Immonen

Address

HYKS Silmaklinikka
PL 220
00029 HUS

Country

Finland

Secondary sponsor category [1]

Individual

Name [1]

Asta Hautamaki

Address [1]

HYKS Silmaklinikka
PL 220
00029 HUS

Country [1]

Finland

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

NKL NSK:n eettinen toimikunta

Ethics committee address [1]

HYKS, NKL NSK eettinen tmk
PL 220
00029 HUS

Ethics committee country [1]

Finland

Date submitted for ethics approval [1]

Approval date [1]

10/01/2008

Ethics approval number [1]

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

Dr Asta Hautamaki

Address

HYKS Silmaklinikka
PL 220
00029 HUS
Finland

Country

Finland

Phone

+358 40 82 22 911

Fax

[email protected]

Contact person for public queries

Name

Asta Hautamaki

Address

HYKS Silmaklinikka
PL 220
00029 HUS

Country

Finland

Phone

+358 50 427 93 13

Fax

[email protected]

Contact person for scientific queries

Name

Ilkka Immonen

Address

HYKS Silmaklinikka
PL 220
00029 HUS

Country

Finland

Phone

+358 9 471 73 167

Fax

[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

Source	Title	Year of Publication	DOI
Embase	ANTERIOR CHAMBER FLARE during BEVACIZUMAB TREATMENT in EYES with EXUDATIVE AGE-RELATED MACULAR DEGENERATION.	2016	https://dx.doi.org/10.1097/IAE.0000000000001061

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically