NCT00684853

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

May 23, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 28, 2008

Completed
Last Updated

May 28, 2008

Status Verified

May 1, 2008

Enrollment Period

6 months

First QC Date

May 23, 2008

Last Update Submit

May 27, 2008

Conditions

Macular Degeneration

Keywords

AMDPDTAvastinBevacizumabFull fluenceexudativeCNVDrusenARMDVetaporfinefficacytreatment

Outcome Measures

Primary Outcomes (1)

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

    4

Secondary Outcomes (3)

  • The overall probability of re-injection

    4

  • 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

    4

  • Mean change in area of leakage, CNV and lesion by the FA and ICG

    4

Study Arms (2)

1

ACTIVE COMPARATOR
Drug: bevacizumabDrug: vetaporfin

2

ACTIVE COMPARATOR
Drug: vetaporfin

Interventions

bevacizumabDRUG

1.25 mg of bevacizumab intravitreal

1
vetaporfinDRUG

full fluence of vetaporfin

12

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNIFESP

São Paulo, São Paulo, 04023-062, Brazil

RECRUITING

Related Publications (12)

  • 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.

    PMID: 18463509BACKGROUND

  • 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.

    PMID: 18462575BACKGROUND

  • 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.

    PMID: 18320527BACKGROUND

  • 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.

    PMID: 18303156BACKGROUND

  • 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.

    PMID: 17923543BACKGROUND

  • 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.

    PMID: 17891013BACKGROUND

  • 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.

    PMID: 17701197BACKGROUND

  • 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.

    PMID: 17564719BACKGROUND

  • 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.

    PMID: 17544776BACKGROUND

  • Lazic R, Gabric N, Dekaris I, Gavric M, Bosnar D. Photodynamic therapy combined with intravitreal bevacizumab (Avastin) in treatment of choroidal neovascularization secondary to age-related macular degeneration. Coll Antropol. 2007 Jan;31 Suppl 1:71-5.

    PMID: 17469756BACKGROUND

  • Costa RA, Jorge R, Calucci D, Melo LA Jr, Cardillo JA, Scott IU. Intravitreal bevacizumab (Avastin) in combination with verteporfin photodynamic therapy for choroidal neovascularization associated with age-related macular degeneration (IBeVe Study). Graefes Arch Clin Exp Ophthalmol. 2007 Sep;245(9):1273-80. doi: 10.1007/s00417-007-0557-x. Epub 2007 Feb 28.

    PMID: 17333238BACKGROUND

  • Augustin AJ, Puls S, Offermann I. Triple therapy for choroidal neovascularization due to age-related macular degeneration: verteporfin PDT, bevacizumab, and dexamethasone. Retina. 2007 Feb;27(2):133-40. doi: 10.1097/IAE.0b013e3180323de7.

    PMID: 17290193BACKGROUND

MeSH Terms

Conditions

Macular Degeneration

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Central Study Contacts

Anderson G Teixeira, MD

CONTACT

323-442-6672anderson.lbo@uol.com.br

Roberta Velletri, MD

CONTACT

11-5511-5085-2041dravelletri@hotmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 23, 2008

First Posted

May 28, 2008

Study Start

November 1, 2007

Primary Completion

May 1, 2008

Last Updated

May 28, 2008

Record last verified: 2008-05

Locations

BR(1)