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Intravitreal Bevacizumab Combined With PDT Versus Bevacizumab to Treat Exudative AMD

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ClinicalTrials.gov Identifier: NCT00684853
Recruitment Status : Unknown
Verified May 2008 by Federal University of São Paulo.
Recruitment status was:  Recruiting
First Posted : May 28, 2008
Last Update Posted : May 28, 2008
Sponsor:
Information provided by:

Study Description
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

Condition or disease Intervention/treatment Phase
Macular Degeneration Drug: bevacizumab Drug: vetaporfin Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intravitreal Bevacizumab Combined With PDT (Full Fluence) Versus Bevacizumab to Treat Exudative Age-Related Macular Degeneration
Study Start Date : November 2007
Primary Completion Date : May 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. The mean change in best-corrected ETDRS visual acuity in the study eye from baseline to 4 months [ Time Frame: 4 ]

Secondary Outcome Measures :
  1. The overall probability of re-injection [ Time Frame: 4 ]
  2. 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 ]
  3. Mean change in area of leakage, CNV and lesion by the FA and ICG [ Time Frame: 4 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00684853


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

Locations
Brazil
UNIFESP Recruiting
Sao Paulo, SP, Brazil, 04023-062
Contact: Roberta Velletri, MD    11-5511-5085-2041    dravelletri@hotmail.com   
Contact: Tessa Mattos, MD    11-5511-5085-2041    tessamattos@hotmail.com   
Sponsors and Collaborators
Federal University of São Paulo
More Information

Publications:

Responsible Party: Anderson Teixeira, MD, UNIFESP
ClinicalTrials.gov Identifier: NCT00684853     History of Changes
Other Study ID Numbers: Pep1
First Posted: May 28, 2008    Key Record Dates
Last Update Posted: May 28, 2008
Last Verified: May 2008

Keywords provided by Federal University of São Paulo:
AMD
PDT
Avastin
Bevacizumab
Full fluence
exudative
CNV
Drusen
ARMD
Vetaporfin
efficacy
treatment

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents