Clinical trial NCT00391144: 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
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Choroidal Neovascularization Secondary to Pattern Dystrophy
Keywords: Pattern Dystrophy
Choroidal Neovascularization
Intravitreal Avastin Injection
Lead sponsor: University of Trieste
Sponsor class: OTHER
First posted: 2006-10-23
Enrollment: 5
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: number of eyes with <15 letter loss (approximately <3 lines) at 6-month examination compared with the baseline value
measure: numeber of eyes with <15 letter loss at 12-month examinations, compared with the baseline value.
Secondary outcomes:
measure: CNV progression
measure: number of injections.
Other outcomes:
Locations:
city: Trieste
country: Italy
facility: Clinica Oculistica, Azienda Ospedaliero-Universitaria di Trieste
state: TS
Study officials:
affiliation: Clinica Oculistica, Azienda Ospedaliero-Universitaria di Trieste
name: Maurizio B Parodi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinica Oculistica, Azienda Ospedaliero-Universitaria di Trieste
name: Pierluigi Iacono, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinica Oculistica, Azienda Ospedaliero-Universitaria di Trieste
name: Giuseppe Ravalico, MD
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.
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.