Completed

Pegaptanib Sodium on Foveal Thickening in Patients With Exudative Subfoveal Age-Related Macular Degeneration (AMD)

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What is being tested

Macugen ™ (pegaptanib sodium injection)

Drug
Who is being recruted

Macular Degeneration

Over 50 Years
+6 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: March 2004

See protocol details

Summary

Principal SponsorEyetech Pharmaceuticals
Last updated: May 3, 2006
Sourced from a government-validated database.Claim as a partner
Study start date: March 1, 2004Actual date on which the first participant was enrolled.

The purpose of this study is to determine if Macugen™ reduces foveal thickness and improves vision in patients with wet AMD. This will be a randomized, double-masked, controlled, dose-ranging, multi-center comparative trial, in parallel groups. Patients will be stratified by clinical center and foveal thickness to be treated either Macugen or a sham injection. After 24 weeks, all patients will treated with Macugen until the end of the study at 54 weeks.

Official TitleA Phase II Prospective, Randomized, Double-Masked, Sham-Controlled, Dose-Ranging, Multi-Center Trial to Assess the Effect of Pegaptanib Sodium on Foveal Thickening in Patients With Exudative Subfoveal Age-Related Macular Degeneration (AMD) 
Principal SponsorEyetech Pharmaceuticals
Last updated: May 3, 2006
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
135 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants receive different combinations of treatments to see how they work together. This approach helps researchers determine whether a combination of treatments is more effective than a single treatment alone.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the interventions assigned to participants is kept confidential
Neither participants nor researchers know who is receiving which treatment. This is the most rigorous way to reduce bias, ensuring that expectations do not influence the results.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 50 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Macular Degeneration
Criteria
3 inclusion criteria required to participate
Best corrected visual acuity in the study eye between 20/40 and 20/320 and better or equal to 20/800 in the fellow eye
Foveal thickness <= 300 um (measured by OCT center point thickness)
Subfoveal choroidal neovascularization secondary to age-related macular degeneration, with a total lesion size (including blood, scar/atrophy \& neovascularization) of <= 12 disc areas, of which at least 50% must be active CNV
3 exclusion criteria prevent from participating
Previous subfoveal thermal laser therapy
Any subfoveal atrophy or scarring, blood over the fovea, or fibrosis. Additionally no more than 25% of the total lesion size may be made up of scarring or atrophy
Previous photodynamic therapy with Visudyne (PDT) in the study eye. Eyes with predominantly classic lesions (as classified by fluorescein angiographic appearance) may be enrolled in the trial if, in the clinical judgment of the investigator, PDT can be deferred for at least 54 weeks after the first study treatment

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has no location dataSave this study to your profile to know when the location data is available. 
CompletedNo study centers