Avastin for CNV Secondary to Pattern Dystrophy

October 20, 2006 updated by: University of Trieste

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Maurizio B Parodi, MD
  • Phone Number: +39 040 772449
  • Email: maubp@yahoo.it

Study Contact Backup

Study Locations

  • Italy
    • TS
      • Trieste, TS, Italy, 34129
        • Recruiting
        • Clinica Oculistica, Azienda Ospedaliero-Universitaria di Trieste
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1/2006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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