Intravitreal Bevacizumab Combined With PDT Versus Bevacizumab to Treat Exudative AMD

The recruitment status of this study is unknown because the information has not been verified recently.

Verified May 2008 by Federal University of São Paulo.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Federal University of São Paulo

ClinicalTrials.gov Identifier:

NCT00684853

First received: May 23, 2008

Last updated: May 27, 2008

Last verified: May 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

May 23, 2008

Last Updated Date

May 27, 2008

Start Date ^ICMJE

November 2007

Primary Completion Date

May 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The mean change in best-corrected ETDRS visual acuity in the study eye from baseline to 4 months [ Time Frame: 4 ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00684853 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

The overall probability of re-injection [ Time Frame: 4 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
Mean change in area of leakage, CNV and lesion by the FA and ICG [ Time Frame: 4 ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Intravitreal Bevacizumab Combined With PDT Versus Bevacizumab to Treat Exudative AMD

Official Title ^ICMJE

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

Brief Summary

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

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 ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Macular Degeneration

Intervention ^ICMJE

Drug: bevacizumab
1.25 mg of bevacizumab intravitreal
Drug: vetaporfin
full fluence of vetaporfin

Study Arm (s)

Active Comparator: 1
Interventions:
- Drug: bevacizumab
- Drug: vetaporfin
Active Comparator: 2
Intervention: Drug: vetaporfin

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

May 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

50 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Anderson G Teixeira, MD	323-442-6672	anderson.lbo@uol.com.br
Contact: Roberta Velletri, MD	11-5511-5085-2041	dravelletri@hotmail.com

Location Countries ^ICMJE

Brazil

Administrative Information

NCT Number ^ICMJE

NCT00684853

Other Study ID Numbers ^ICMJE

Pep1

Has Data Monitoring Committee

Yes

Responsible Party

Anderson Teixeira, MD, UNIFESP

Study Sponsor ^ICMJE

Federal University of São Paulo

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

Information Provided By

Federal University of São Paulo

Verification Date

May 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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