Avastin for CNV Secondary to Pattern Dystrophy - Full Text View

Sponsored by:	University of Trieste
Information provided by:	University of Trieste
ClinicalTrials.gov Identifier:	NCT00391144

Purpose

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.

Condition	Intervention	Phase
Choroidal Neovascularization Secondary to Pattern Dystrophy	Procedure: intravitreal triamcinolone injection of avastin (1.25 mg)	Phase II Phase III

Drug Information available for: Triamcinolone diacetate Triamcinolone acetonide Bevacizumab Triamcinolone Triamcinolone hexacetonide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Single Blind, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Intravitreal Avastin Injection for the Treatment of Choroidal Neovascularization Secondary to Pattern Dystrophy

Further study details as provided by University of Trieste:

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.

Estimated Enrollment:	5
Study Start Date:	July 2006
Estimated Study Completion Date:	October 2006

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

Ages Eligible for Study:	20 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00391144

Contacts

Contact: Maurizio B Parodi, MD	+39 040 772449	maubp@yahoo.it
Contact: Giuseppe Ravalico, MD	+39 040 772449	giuseppe.ravalico@aots.sanita.fvg.it

Locations

Italy, TS
Clinica Oculistica, Azienda Ospedaliero-Universitaria di Trieste	Recruiting
Trieste, TS, Italy, 34129
Contact: Giuseppe Ravalico, MD +39 040 772449 giuseppe.ravalico@aots.sanita.fvg.it
Contact: Giuseppe Ravalico, MD +39 040 772449 giuseppe.ravalico@aots.sanita.fvg.it

Sponsors and Collaborators

University of Trieste

Investigators

Principal Investigator:	Maurizio B Parodi, MD	Clinica Oculistica, Azienda Ospedaliero-Universitaria di Trieste
Principal Investigator:	Pierluigi Iacono, MD	Clinica Oculistica, Azienda Ospedaliero-Universitaria di Trieste
Study Director:	Giuseppe Ravalico, MD	Clinica Oculistica, Azienda Ospedaliero-Universitaria di Trieste

More Information

Publications:

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.

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.

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

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.

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.

Study ID Numbers:	1/2006
Study First Received:	October 20, 2006
Last Updated:	October 20, 2006
ClinicalTrials.gov Identifier:	NCT00391144 History of Changes
Health Authority:	Italy: National Institute of Health

Keywords provided by University of Trieste:

Pattern Dystrophy
Choroidal Neovascularization
Intravitreal Avastin Injection

Study placed in the following topic categories:

Anti-Inflammatory Agents
Hormone Antagonists
Eye Diseases
Choroid Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Triamcinolone diacetate
Bevacizumab
Angiogenesis Inhibitors
Hormones

Glucocorticoids
Choroidal Neovascularization
Triamcinolone hexacetonide
Triamcinolone Acetonide
Metaplasia
Triamcinolone
Neoplasm Metastasis
Neovascularization, Pathologic

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Uveal Diseases
Antineoplastic Agents
Growth Substances
Eye Diseases
Physiological Effects of Drugs
Choroid Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Bevacizumab
Angiogenesis Inhibitors
Hormones
Glucocorticoids

Pharmacologic Actions
Choroidal Neovascularization
Neoplastic Processes
Neoplasms
Pathologic Processes
Therapeutic Uses
Metaplasia
Triamcinolone
Neoplasm Metastasis
Growth Inhibitors
Angiogenesis Modulating Agents
Neovascularization, Pathologic

ClinicalTrials.gov processed this record on May 07, 2009