Avastin for CNV Secondary to Pattern Dystrophy

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

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.

Study Overview

• Status: Unknown
• Conditions: Choroidal Neovascularization Secondary to Pattern Dystrophy
• Intervention / Treatment: Procedure: intravitreal triamcinolone injection of avastin (1.25 mg)

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.

• Study Type: Interventional
• Enrollment: 5
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
CNV progression
number of injections.

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General 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. doi: 10.1016/j.ajo.2006.01.038.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2006
• Study Completion: October 1, 2006

Study Registration Dates

• First Submitted: October 20, 2006
• First Submitted That Met QC Criteria: October 20, 2006
• First Posted (Estimate): October 23, 2006

Study Record Updates

• Last Update Posted (Estimate): October 23, 2006
• Last Update Submitted That Met QC Criteria: October 20, 2006
• Last Verified: October 1, 2006

More Information

Terms related to this study

• Keywords: Choroidal Neovascularization; Pattern Dystrophy; Intravitreal Avastin Injection
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Eye Diseases; Uveal Diseases; Neoplastic Processes; Choroid Diseases; Metaplasia; Neoplasm Metastasis; Choroidal Neovascularization; Neovascularization, Pathologic; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antineoplastic Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Bevacizumab; Triamcinolone
• Other Study ID Numbers: 1/2006