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Intravitreal Bevacizumab Combined With PDT Versus Bevacizumab to Treat Exudative AMD

Primary Purpose

Macular Degeneration

Status
Unknown status
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
bevacizumab
vetaporfin
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Degeneration focused on measuring AMD, PDT, Avastin, Bevacizumab, Full fluence, exudative, CNV, Drusen, ARMD, Vetaporfin, efficacy, treatment

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UNIFESPRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

The mean change in best-corrected ETDRS visual acuity in the study eye from baseline to 4 months

Secondary Outcome Measures

The overall probability of re-injection
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
Mean change in area of leakage, CNV and lesion by the FA and ICG

Full Information

First Posted
May 23, 2008
Last Updated
May 27, 2008
Sponsor
Federal University of São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT00684853
Brief Title
Intravitreal Bevacizumab Combined With PDT Versus Bevacizumab to Treat Exudative AMD
Official Title
Intravitreal Bevacizumab Combined With PDT (Full Fluence) Versus Bevacizumab to Treat Exudative Age-Related Macular Degeneration
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Unknown status
Study Start Date
November 2007 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Federal University of São Paulo

4. Oversight

Data Monitoring Committee
Yes

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Degeneration
Keywords
AMD, PDT, Avastin, Bevacizumab, Full fluence, exudative, CNV, Drusen, ARMD, Vetaporfin, efficacy, treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
bevacizumab
Intervention Description
1.25 mg of bevacizumab intravitreal
Intervention Type
Drug
Intervention Name(s)
vetaporfin
Intervention Description
full fluence of vetaporfin
Primary Outcome Measure Information:
Title
The mean change in best-corrected ETDRS visual acuity in the study eye from baseline to 4 months
Time Frame
4
Secondary Outcome Measure Information:
Title
The overall probability of re-injection
Time Frame
4
Title
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
Title
Mean change in area of leakage, CNV and lesion by the FA and ICG
Time Frame
4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anderson G Teixeira, MD
Phone
323-442-6672
Email
anderson.lbo@uol.com.br
First Name & Middle Initial & Last Name or Official Title & Degree
Roberta Velletri, MD
Phone
11-5511-5085-2041
Email
dravelletri@hotmail.com
Facility Information:
Facility Name
UNIFESP
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04023-062
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roberta Velletri, MD
Phone
11-5511-5085-2041
Email
dravelletri@hotmail.com
First Name & Middle Initial & Last Name & Degree
Tessa Mattos, MD
Phone
11-5511-5085-2041
Email
tessamattos@hotmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
18463509
Citation
Smith BT, Dhalla MS, Shah GK, Blinder KJ, Ryan EH Jr, Mittra RA. Intravitreal injection of bevacizumab combined with verteporfin photodynamic therapy for choroidal neovascularization in age-related macular degeneration. Retina. 2008 May;28(5):675-81. doi: 10.1097/IAE.0b013e31816b316e.
Results Reference
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PubMed Identifier
18462575
Citation
Colquitt JL, Jones J, Tan SC, Takeda A, Clegg AJ, Price A. Ranibizumab and pegaptanib for the treatment of age-related macular degeneration: a systematic review and economic evaluation. Health Technol Assess. 2008 May;12(16):iii-iv, ix-201. doi: 10.3310/hta12160.
Results Reference
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PubMed Identifier
18320527
Citation
Ahmadieh H, Taei R, Soheilian M, Riazi-Esfahani M, Ahadi H. Single-session photodynamic therapy combined with intravitreal bevacizumab for neovascular age-related macular degeneration. Eur J Ophthalmol. 2008 Mar-Apr;18(2):297-300. doi: 10.1177/112067210801800222.
Results Reference
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PubMed Identifier
18303156
Citation
Weigert G, Michels S, Sacu S, Varga A, Prager F, Geitzenauer W, Schmidt-Erfurth U. Intravitreal bevacizumab (Avastin) therapy versus photodynamic therapy plus intravitreal triamcinolone for neovascular age-related macular degeneration: 6-month results of a prospective, randomised, controlled clinical study. Br J Ophthalmol. 2008 Mar;92(3):356-60. doi: 10.1136/bjo.2007.125823.
Results Reference
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PubMed Identifier
17923543
Citation
Bashshur ZF, Schakal A, Hamam RN, El Haibi CP, Jaafar RF, Noureddin BN. Intravitreal bevacizumab vs verteporfin photodynamic therapy for neovascular age-related macular degeneration. Arch Ophthalmol. 2007 Oct;125(10):1357-61. doi: 10.1001/archopht.125.10.1357.
Results Reference
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PubMed Identifier
17891013
Citation
Ladas ID, Kotsolis AI, Papakostas TD, Rouvas AA, Karagiannis DA, Vergados I. Intravitreal bevacizumab combined with photodynamic therapy for the treatment of occult choroidal neovascularization associated with serous pigment epithelium detachment in age-related macular degeneration. Retina. 2007 Sep;27(7):891-6. doi: 10.1097/IAE.0b013e3180ca9ad9.
Results Reference
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PubMed Identifier
17701197
Citation
Ladewig MS, Karl SE, Hamelmann V, Helb HM, Scholl HP, Holz FG, Eter N. Combined intravitreal bevacizumab and photodynamic therapy for neovascular age-related macular degeneration. Graefes Arch Clin Exp Ophthalmol. 2008 Jan;246(1):17-25. doi: 10.1007/s00417-007-0654-x. Epub 2007 Aug 15.
Results Reference
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PubMed Identifier
17564719
Citation
Hahn R, Sacu S, Michels S, Varga A, Weigert G, Geitzenauer W, Vecsei-Marlovits P, Schmidt-Erfurth U. [Intravitreal bevacizumab versus verteporfin and intravitreal triamcinolone acetonide in patients with neovascular age-related macula degeneration]. Ophthalmologe. 2007 Jul;104(7):588-93. doi: 10.1007/s00347-007-1547-4. German.
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PubMed Identifier
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Citation
Lazic R, Gabric N. Verteporfin therapy and intravitreal bevacizumab combined and alone in choroidal neovascularization due to age-related macular degeneration. Ophthalmology. 2007 Jun;114(6):1179-85. doi: 10.1016/j.ophtha.2007.03.006.
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PubMed Identifier
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Citation
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Citation
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Citation
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Intravitreal Bevacizumab Combined With PDT Versus Bevacizumab to Treat Exudative AMD

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