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Macular DegenerationPhase 2NCT00684853

Intravitreal Bevacizumab Combined With PDT Versus Bevacizumab to Treat Exudative AMD

A Phase 2 study testing bevacizumab and vetaporfin in people with Macular Degeneration, run by Federal University of São Paulo at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Macular Degeneration
What is being tested?
bevacizumab and vetaporfin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteBrazil
Study dates
Nov 2007to May 2008
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • acuite uveits
  • history of endophthalmites
  • vitreous hemorrhage
  • geographic atrophy or fibrosis corresponding > 50% of the lesion

Trial locations and contacts

1 site in 1 country.

Anderson G Teixeira, MD contact

323-442-6672

anderson.lbo@uol.com.br

Roberta Velletri, MD contact

11-5511-5085-2041

dravelletri@hotmail.com

Brazil1 site, 1 recruiting

  • UNIFESP

    São Paulo, São Paulo, 04023-062

    Roberta Velletri, MD, 11-5511-5085-2041, dravelletri@hotmail.com

    Tessa Mattos, MD, 11-5511-5085-2041, tessamattos@hotmail.com

    Recruiting

Other trials in Brazil

About this study

Official title: 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

Read the 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.

Being tested
bevacizumab, vetaporfin
Keywords
AMD, PDT, Avastin, Bevacizumab, Full fluence, exudative, CNV, Drusen, ARMD, Vetaporfin, efficacy, treatment
Medical subject headings
Macular Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bevacizumabDrug

    1.25 mg of bevacizumab intravitreal

  • vetaporfinDrug

    full fluence of vetaporfin

Study groups in NCT00684853
Study groupRoleWhat they receive
1Active comparatorNot described
Receives: Drug: bevacizumab; Drug: vetaporfin
2Active comparatorNot described
Receives: Drug: vetaporfin

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 4

Secondary outcomes (3)

  1. The overall probability of re-injection

    Measured: 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

    Measured: 4

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

    Measured: 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2008 (estimated)
  2. Study startNov 2007
  3. Primary completionMay 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00684853
Sponsor's protocol ID
Pep1
Status last verified
May 2008
First submitted
23 May 2008
Last updated
28 May 2008
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 18463509

  • 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.

    PubMed 18462575

  • 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.

    PubMed 18320527

  • 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.

    PubMed 18303156

  • 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.

    PubMed 17923543

  • 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.

    PubMed 17891013

  • 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.

    PubMed 17701197

  • 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.

    PubMed 17564719

  • 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.

    PubMed 17544776

  • 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.

    PubMed 17469756

  • 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.

    PubMed 17333238

  • 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.

    PubMed 17290193

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing bevacizumab and vetaporfin in people with Macular Degeneration, run by Federal University of São Paulo at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 May 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Anderson G Teixeira, MD (323-442-6672, anderson.lbo@uol.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The mean change in best-corrected ETDRS visual acuity in the study eye from baseline to 4 months (time frame: 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00684853, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2008.

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