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NCT00391144 Clinical Trial

Avastin for CNV Secondary to Pattern Dystrophy

Choroidal Neovascularization Secondary to Pattern Dystrophy Clinical Trial

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

Clinical Trial Details — Status: Unknown status

Administrative data
NCT number NCT00391144
Other study ID # 1/2006
Secondary ID
Status Unknown status
Phase Phase 2/Phase 3
First received October 20, 2006
Last updated October 20, 2006
Start date July 2006
Est. completion date October 2006

Study information
Verified date October 2006
Source University of Trieste
Contact Maurizio B Parodi, MD
Phone +39 040 772449
Email maubp@yahoo.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Unknown status
Enrollment 5
Est. completion date October 2006
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• intravitreal triamcinolone injection of avastin (1.25 mg)

Locations
Country Name City State
Italy Clinica Oculistica, Azienda Ospedaliero-Universitaria di Trieste Trieste TS

Sponsors (1)
Lead Sponsor Collaborator
University of Trieste

Country where clinical trial is conducted

Italy, 

References & Publications (5)

Battaglia Parodi M, Da Pozzo S, Ravalico G. Photodynamic therapy for choroidal neovascularization associated with pattern dystrophy. Retina. 2003 Apr;23(2):171-6. — View 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. — View 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. — View 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. — View 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 seri — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary number of eyes with <15 letter loss (approximately <3 lines) at 6-month examination compared with the baseline value
Primary numeber of eyes with <15 letter loss at 12-month examinations, compared with the baseline value.
Secondary CNV progression
Secondary number of injections.