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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

May 23, 2008
May 27, 2008
November 2007
May 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00684853 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Intravitreal Bevacizumab Combined With PDT Versus Bevacizumab to Treat Exudative AMD
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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Macular Degeneration
  • Drug: bevacizumab
    1.25 mg of bevacizumab intravitreal
  • Drug: vetaporfin
    full fluence of vetaporfin
  • Active Comparator: 1
    Interventions:
    • Drug: bevacizumab
    • Drug: vetaporfin
  • Active Comparator: 2
    Intervention: Drug: vetaporfin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
Not Provided
May 2008   (final data collection date for primary outcome measure)

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
Both
50 Years and older
No
Contact: Anderson G Teixeira, MD 323-442-6672 anderson.lbo@uol.com.br
Contact: Roberta Velletri, MD 11-5511-5085-2041 dravelletri@hotmail.com
Brazil
 
NCT00684853
Pep1
Yes
Anderson Teixeira, MD, UNIFESP
Federal University of São Paulo
Not Provided
Not Provided
Federal University of São Paulo
May 2008

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