Macugen (Pegaptanib Sodium) Alone, Versus Macugen in Combination With PDT (Photodynamic Therapy) With Visudyne (Verteporfin) in Patients With Age-Related Macular Degeneration (AMD)

This study has been terminated.

Sponsors and Collaborators:	Eyetech Pharmaceuticals Pfizer
Information provided by:	Eyetech Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00134667

Purpose

The purpose of the trial is to compare whether Macugen (pegaptanib sodium) in combination with PDT with Visudyne (verteporfin) is safe and effective in slowing down the leakage of fluid within the eye and thereby stabilizing or improving vision when compared to Macugen alone. Patients must be recently diagnosed with predominantly classic wet AMD and must be eligible for PDT.

Condition	Intervention	Phase
Age-Related Macular Degeneration	Drug: Photodynamic Therapy (PDT) with Visudyne (verteporfin) Drug: Macugen (pegaptanib sodium)	Phase IV

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

Drug Information available for: Pegaptanib sodium Verteporfin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase IIIb/IV Randomized, Double-Masked, Active Controlled, Dose-Ranging, Multi-Center Comparative Trial, in Parallel Groups, to Compare the Safety and Efficacy of Intravitreal Injections of Pegaptanib Sodium (Macugen) Given Every 6 Weeks for 102 Weeks, to Pegaptanib Sodium Plus Photodynamic Therapy (PDT) With Visudyne, in Patients With Exudative Age-Related Macular Degeneration (AMD)

Further study details as provided by Eyetech Pharmaceuticals:

Estimated Enrollment:	360
Study Start Date:	March 2005
Estimated Study Completion Date:	October 2008

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects of either gender; aged 50 years or greater.
Subfoveal choroidal neovascularization (CNV) due to AMD with predominantly classic lesion composition
Best corrected visual acuity in the study eye between 20/40 and 20/200

Exclusion Criteria:

Any prior PDT with Visudyne to the study eye
Any previous AMD thermal laser therapy to the study eye

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00134667

Locations

United States, Arizona
Retina Centers, P.C., Northwest Location
Tucson, Arizona, United States, 85704-5614

Sponsors and Collaborators

Eyetech Pharmaceuticals

Pfizer

More Information

Study ID Numbers:	EOP1012
Study First Received:	August 24, 2005
Last Updated:	January 12, 2007
ClinicalTrials.gov Identifier:	NCT00134667
Health Authority:	United States: Food and Drug Administration

Keywords provided by Eyetech Pharmaceuticals:

AMD
Age-Related Macular Degeneration
Macular Degeneration
Macugen
Photodynamic Therapy
PDT

Visudyne
pegaptanib sodium
verteporfin
Predominantly Classic
Age-Related Macular Degeneration (AMD)

Study placed in the following topic categories:

Eye Diseases
Verteporfin
Retinal Degeneration

Macular Degeneration
Retinal Diseases
Retinal degeneration

Additional relevant MeSH terms:

Photosensitizing Agents
Radiation-Sensitizing Agents
Therapeutic Uses

Physiological Effects of Drugs
Dermatologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009