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Avastin for CNV Secondary to Pattern Dystrophy

Primary Purpose

Choroidal Neovascularization Secondary to Pattern Dystrophy

Status

Unknown status

Phase

Phase 2

Locations

Italy

Study Type

Interventional

Intervention

intravitreal triamcinolone injection of avastin (1.25 mg)

About this trial

This is an interventional treatment trial for Choroidal Neovascularization Secondary to Pattern Dystrophy focused on measuring Pattern Dystrophy, Choroidal Neovascularization, Intravitreal Avastin Injection

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Clinica Oculistica, Azienda Ospedaliero-Universitaria di TriesteRecruiting

Outcomes

Primary Outcome Measures

number of eyes with <15 letter loss (approximately <3 lines) at 6-month examination compared with the baseline value

numeber of eyes with <15 letter loss at 12-month examinations, compared with the baseline value.

Secondary Outcome Measures

CNV progression

number of injections.

Full Information

NCT ID

NCT00391144

First Posted

October 20, 2006

Last Updated

October 20, 2006

Sponsor

University of Trieste

1. Study Identification

Unique Protocol Identification Number

NCT00391144

Brief Title

Avastin for CNV Secondary to Pattern Dystrophy

Official Title

Intravitreal Avastin Injection for the Treatment of Choroidal Neovascularization Secondary to Pattern Dystrophy

Study Type

Interventional

2. Study Status

Record Verification Date

October 2006

Overall Recruitment Status

Unknown status

Study Start Date

July 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

October 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

University of Trieste

4. Oversight

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Choroidal Neovascularization Secondary to Pattern Dystrophy

Keywords

Pattern Dystrophy, Choroidal Neovascularization, Intravitreal Avastin Injection

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

Single

Allocation

Non-Randomized

Enrollment

5 (false)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

intravitreal triamcinolone injection of avastin (1.25 mg)

Primary Outcome Measure Information:

Title

number of eyes with <15 letter loss (approximately <3 lines) at 6-month examination compared with the baseline value

Title

numeber of eyes with <15 letter loss at 12-month examinations, compared with the baseline value.

Secondary Outcome Measure Information:

Title

CNV progression

Title

number of injections.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Maurizio B Parodi, MD

Phone

+39 040 772449

maubp@yahoo.it

First Name & Middle Initial & Last Name or Official Title & Degree

Giuseppe Ravalico, MD

Phone

+39 040 772449

giuseppe.ravalico@aots.sanita.fvg.it

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Maurizio B Parodi, MD

Organizational Affiliation

Clinica Oculistica, Azienda Ospedaliero-Universitaria di Trieste

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Pierluigi Iacono, MD

Organizational Affiliation

Clinica Oculistica, Azienda Ospedaliero-Universitaria di Trieste

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Giuseppe Ravalico, MD

Organizational Affiliation

Clinica Oculistica, Azienda Ospedaliero-Universitaria di Trieste

Official's Role

Study Director

Facility Information:

Facility Name

Clinica Oculistica, Azienda Ospedaliero-Universitaria di Trieste

City

Trieste

State/Province

ZIP/Postal Code

34129

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Giuseppe Ravalico, MD

Phone

+39 040 772449

giuseppe.ravalico@aots.sanita.fvg.it

12. IPD Sharing Statement

Citations:

PubMed Identifier

16765697

Citation

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.

Results Reference

result

PubMed Identifier

11741106

Citation

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.

Results Reference

result

PubMed Identifier

12707595

Citation

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.

Results Reference

result

PubMed Identifier

11071039

Citation

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.

Results Reference

result

PubMed Identifier

8720722

Citation

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.

Results Reference

result

PubMed Identifier

20375343

Citation

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.

Results Reference

derived

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Avastin for CNV Secondary to Pattern Dystrophy

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