Intravitreal Bevacizumab Combined With PDT Versus Bevacizumab to Treat Exudative AMD

May 27, 2008 updated by: Federal University of São Paulo

Intravitreal Bevacizumab Combined With PDT (Full Fluence) Versus Bevacizumab to Treat Exudative Age-Related Macular Degeneration

The purpose of this study is to determine the association of bevacizumab and PDT is safety and effective in the treatment of exudative AMD

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Exudative AMD is the leader of blind in people more than 60 years. The best treatment for this disease today are monthly injections of anti-VEGF in the vitreous cavity which increase the chance to get endophthalmites.

The participants of this study will be randomized in 1:1 ration to one of the two study groups: single therapy of bevacizumab (3 injections in 3 months) or association of bevacizumab (3 injections in 3 months) and full fluence of PDT (single at the baseline). All bevacizumab injection will contain 1.25g of the drug and will be administrate every month for 3 continuos months.

After randomization, participants will return to the clinic approximately every four weeks for 4 months for study assessments and possible re-treatment (if is necessary). Participants will return to the clinic at week 20 for a final study assessment. Study assessments include: visual acuity, optical coherence tomography and fundus photography.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2

Contacts and Locations

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

Study Locations

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

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • more or iqual 50 years old
  • male or female
  • Choroidal neovascularization sub or just foveal the fovea secondary to AMD (Predominantly Classic, Minimally Classic, and Occult lesions acceptable)
  • Greatest linear dimension (GLD) of entire lesion < 5400 µm (no reading center confirmation required)
  • ETDRS best corrected visual acuity of 20/40 - 20/320 (73 - 24 letter score)
  • Total area of lesion must < 9 MPS DA

Exclusion Criteria:

  • pre-treatment
  • ETDRS best corrected visual acuity better than 34 letters
  • macular surgery history
  • laser photocoagulation in the study eye within 30 dais
  • eye surgery within 30 days
  • history of no-treat glaucoma
  • acuite uveits
  • history of endophthalmites
  • vitreous hemorrhage
  • geographic atrophy or fibrosis corresponding > 50% of the lesion

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
Drug: bevacizumab
1.25 mg of bevacizumab intravitreal
Drug: vetaporfin
full fluence of vetaporfin
ACTIVE_COMPARATOR: 2
Drug: vetaporfin
full fluence of vetaporfin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The mean change in best-corrected ETDRS visual acuity in the study eye from baseline to 4 months
Time Frame: 4
4

Secondary Outcome Measures

Outcome Measure
Time Frame
The overall probability of re-injection
Time Frame: 4
4
Proportion of participants with reduction in retinal thickening in the center subfield (i.e., thickness > 200 microns) of ³50% and of at least 50 microns from baseline
Time Frame: 4
4
Mean change in area of leakage, CNV and lesion by the FA and ICG
Time Frame: 4
4

Collaborators and Investigators

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

Sponsor

Federal University of São Paulo

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

November 1, 2007

Primary Completion (ACTUAL)

May 1, 2008

Study Registration Dates

First Submitted

May 23, 2008

First Submitted That Met QC Criteria

May 27, 2008

First Posted (ESTIMATE)

May 28, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

May 28, 2008

Last Update Submitted That Met QC Criteria

May 27, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pep1

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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