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Avastin for CNV Secondary to Pattern Dystrophy

NCT ID: NCT00391144

Last Updated: 2006-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2006-10-31

Brief Summary

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The natural history of subfoveal CNV secondary to Pattern Dystrophy is little understood, but it seems that visual function may be preserved only in the short-term follow-up, with progressive deterioration thereafter.

Photodynamic therapy with verteporfin is the most studied therapeuthic option for this kindf of lesion, but unfortunately, this approach does not appear to guarantee long-term vision stabilization, and alternative therapies should be investigated.

Detailed Description

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Diagnosis of Pattern Dystrophy Diagnosis of subfoveal CNV Intravitreal injection of avastin (1.25 mg) in operating room under sterile condition.

Retreatment on the basis of the detection of disease progression and of lack of central retinal thickness reduction on OCT.

Conditions

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Choroidal Neovascularization Secondary to Pattern Dystrophy

Keywords

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Pattern Dystrophy Choroidal Neovascularization Intravitreal Avastin Injection

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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intravitreal triamcinolone injection of avastin (1.25 mg)

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* diagnosis of RPD (hyperpigmented yellowish-greyish network, other family members sharing RPD, normal electroretinogram and normal/subnormal electrooculogram)
* classic or occult CNV involving the foveal avascular zone's geometric centre

Exclusion Criteria

* conditions other than RPD
* intraocular surgery or capsulotomy within the last 2 or 1 months
* pregnancy
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Trieste

OTHER

Sponsor Role lead

Principal Investigators

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Maurizio B Parodi, MD

Role: PRINCIPAL_INVESTIGATOR

Clinica Oculistica, Azienda Ospedaliero-Universitaria di Trieste

Pierluigi Iacono, MD

Role: PRINCIPAL_INVESTIGATOR

Clinica Oculistica, Azienda Ospedaliero-Universitaria di Trieste

Giuseppe Ravalico, MD

Role: STUDY_DIRECTOR

Clinica Oculistica, Azienda Ospedaliero-Universitaria di Trieste

Locations

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Clinica Oculistica, Azienda Ospedaliero-Universitaria di Trieste

Trieste, TS, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Maurizio B Parodi, MD

Role: CONTACT

Phone: +39 040 772449

Email: [email protected]

Giuseppe Ravalico, MD

Role: CONTACT

Phone: +39 040 772449

Email: [email protected]

Facility Contacts

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Giuseppe Ravalico, MD

Role: primary

References

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Parodi MB, Liberali T, Pedio M, Francis PJ, Piccolino FC, Fiotti N, Romano M, Ravalico G. Photodynamic therapy of subfoveal choroidal neovascularization secondary to reticular pattern dystrophy: three-year results of an uncontrolled, prospective case series. Am J Ophthalmol. 2006 Jun;141(6):1152-4. doi: 10.1016/j.ajo.2006.01.038.

Reference Type RESULT
PMID: 16765697 (View on PubMed)

Da Pozzo S, Parodi MB, Toto L, Ravalico G. Occult choroidal neovascularization in adult-onset foveomacular vitelliform dystrophy. Ophthalmologica. 2001 Nov-Dec;215(6):412-4. doi: 10.1159/000050899.

Reference Type RESULT
PMID: 11741106 (View on PubMed)

Battaglia Parodi M, Da Pozzo S, Ravalico G. Photodynamic therapy for choroidal neovascularization associated with pattern dystrophy. Retina. 2003 Apr;23(2):171-6. doi: 10.1097/00006982-200304000-00006.

Reference Type RESULT
PMID: 12707595 (View on PubMed)

Battaglia Parodi M, Di Crecchio L, Ravalico G. Vascularized pigment epithelial detachment in adult-onset foveomacular vitelliform dystrophy. Eur J Ophthalmol. 2000 Jul-Sep;10(3):266-9. doi: 10.1177/112067210001000315.

Reference Type RESULT
PMID: 11071039 (View on PubMed)

Battaglia Parodi M, Iustulin D, Russo D, Ravalico G. Adult-onset foveomacular vitelliform dystrophy and indocyanine green videoangiography. Graefes Arch Clin Exp Ophthalmol. 1996 Mar;234(3):208-11. doi: 10.1007/BF00462035.

Reference Type RESULT
PMID: 8720722 (View on PubMed)

Parodi MB, Iacono P, Cascavilla M, Zucchiatti I, Kontadakis DS, Bandello F. Intravitreal bevacizumab for subfoveal choroidal neovascularization associated with pattern dystrophy. Invest Ophthalmol Vis Sci. 2010 Sep;51(9):4358-61. doi: 10.1167/iovs.10-5237. Epub 2010 Apr 7.

Reference Type DERIVED
PMID: 20375343 (View on PubMed)

Other Identifiers

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1/2006

Identifier Type: -

Identifier Source: org_study_id