Intravitreal Bevacizumab Combined With PDT Versus Bevacizumab to Treat Exudative AMD

Macular Degeneration Clinical Trial

Official title:

Intravitreal Bevacizumab Combined With PDT (Full Fluence) Versus Bevacizumab to Treat Exudative Age-Related Macular Degeneration

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00684853
• Other study ID #: Pep1
• Status: Recruiting
• Phase: Phase 2
• First received: May 23, 2008
• Last updated: May 27, 2008
• Start date: November 2007

Study information

• Verified date: May 2008
• Source: Federal University of São Paulo
• Contact: Anderson G Teixeira, MD
• Phone: 323-442-6672
• Email: anderson.lbo[@]uol.com.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Macular Degeneration

Intervention

Drug:
• bevacizumab
1.25 mg of bevacizumab intravitreal
• vetaporfin
full fluence of vetaporfin

Locations

Country	Name	City	State
Brazil	UNIFESP	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (12)

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. — View Citation

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. — View 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. — View 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. Review. — View Citation

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. Epub 2007 Feb 28. — View Citation

Hahn R, Sacu S, Michels S, Varga A, Weigert G, Geitzenauer W, Vécsei-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. German. — View 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. — View 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. Epub 2007 Aug 15. — View Citation

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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The mean change in best-corrected ETDRS visual acuity in the study eye from baseline to 4 months		4	Yes
Secondary	The overall probability of re-injection		4	Yes
Secondary	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	Yes
Secondary	Mean change in area of leakage, CNV and lesion by the FA and ICG		4	Yes