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
  Purpose

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 Intervention Phase
Macular Degeneration
Drug: bevacizumab
Drug: vetaporfin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intravitreal Bevacizumab Combined With PDT (Full Fluence) Versus Bevacizumab to Treat Exudative Age-Related Macular Degeneration

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Study Start Date: November 2007
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: May 23, 2008
Last Updated: May 27, 2008
Health Authority: Brazil: National Committee of Ethics in Research

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
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 31, 2014