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Evaluation Of Safety And Efficacy Of 0.3 Mg/Eye Macugen In Patients With Small Age-Related Macular Degeneration Lesions

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Angers, Cedex 09, 49933 France
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Macular Degeneration
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
50+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Clinical and angiographic evidence of juxtafoveal or subfoveal choroidal
neovascularization secondary to AMD with a total lesion size of less than 2 MPS disc
areas

- Best-corrected visual acuity in the study eye greater than 54 letters (ETDRS)

- Women must be using 2 forms of effective contraception

- Adequate hematological, renal and liver functions

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Any atrophy or fibrosis; any retinal hemorrhage measuring more than 1 disc area

- Any extrafoveal choroidal neovascularization

- Any intraocular surgery or thermal laser to the study eye within 3 months of
enrollment

- Previous or concomitant therapy for AMD including PDT with verteporfin (Visudyne) or
subfoveal/non-foveal thermal laser therapy, transpupillary thermotherapy, external
beam radiation, submacular surgery.

- Presence of other causes of choroidal neovascularization, including pathological
myopia, the ocular histoplasmosis syndrome, angioid streaks, choroidal rupture and
multifocal choroiditis

NCT00324116
Pfizer
Completed
Evaluation Of Safety And Efficacy Of 0.3 Mg/Eye Macugen In Patients With Small Age-Related Macular Degeneration Lesions

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Evaluation Of Safety And Efficacy Of 0.3 Mg/Eye Macugen In Patients With Small Age-Related Macular Degeneration Lesions
A Prospective, Open-Label Multi Center Trial Evaluating The Safety And Efficacy Of 0.3 Mg/Eye Pegaptanib Sodium (Macugen) Intravitreous Injection Given Every 6 Weeks For 54 Weeks In Patients With Small Neovascular Age-Related Macular Degeneration (AMD) Lesions
To evaluate the efficacy, based on the best-corrected visual acuity (using the ETDRS chart), of a 0.3 mg/eye pegaptanib sodium intravitreous injection given every 6 weeks for 54 weeks in patients with exudative age-related macular degeneration and evidence of recent onset, subfoveal and/or juxtafoveal choroidal neovascularization.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Macular Degeneration
Drug: pegaptanib sodium (Macugen)
0.3 MG/eye pegaptanib IB sodium by intravitreous injection given every 6 weeks for 54 weeks.
Other Name: MACUGEN
Experimental: Active
Intervention: Drug: pegaptanib sodium (Macugen)
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
81
August 2008
August 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clinical and angiographic evidence of juxtafoveal or subfoveal choroidal neovascularization secondary to AMD with a total lesion size of less than 2 MPS disc areas
  • Best-corrected visual acuity in the study eye greater than 54 letters (ETDRS)
  • Women must be using 2 forms of effective contraception
  • Adequate hematological, renal and liver functions

Exclusion Criteria:

  • Any atrophy or fibrosis; any retinal hemorrhage measuring more than 1 disc area
  • Any extrafoveal choroidal neovascularization
  • Any intraocular surgery or thermal laser to the study eye within 3 months of enrollment
  • Previous or concomitant therapy for AMD including PDT with verteporfin (Visudyne) or subfoveal/non-foveal thermal laser therapy, transpupillary thermotherapy, external beam radiation, submacular surgery.
  • Presence of other causes of choroidal neovascularization, including pathological myopia, the ocular histoplasmosis syndrome, angioid streaks, choroidal rupture and multifocal choroiditis
Sexes Eligible for Study: All
50 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00324116
A5751016
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer Inc
Pfizer
ITEC GROUP 3
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2010

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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