An open label, non-comparative protocol for the use of pegaptanib sodium injection every 6 weeks in patients with exudative age-related macular degeneration (AMD). - N/A

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-004296-11-GB

Enrollment

150

Registered

2005-02-23

Start date

2005-07-12

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exudative Age Related Macular Degeneration (AMD) MedDRA version: 8 Level: LLT Classification code 10025411

Interventions

Trade Name: Macugen Pharmaceutical Form: Solution for injection INN or Proposed INN: Pegaptanib Sodium Current Sponsor code: EYE 001 Oth

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Ophthalmic Criteria 1. Best corrected visual acuity in the study eye worse than 20/40. 2. Subfoveal choroidal neovascularization, secondary to age related macular degeneration, with a total lesion size [including blood, scar/atrophy & neovascularization] of =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patients will not be eligible for treatment if any of the following criteria are present systemically or in the study eye: 1. Any subfoveal scarring or atrophy and no more than 25% of the total lesion size may be made up of scarring or atrophy. 2. Patients who are eligible for any other of the Sponsor’s ongoing AMD studies still open to enrollment. 3. Presence of other causes of choroidal neovascularization, including pathologic myopia (spherical equivalent of –8 diopters or more, or axial length of 25mm or more), the ocular histoplasmosis syndrome, angioid streaks, choroidal rupture and multifocal choroiditis. 4. Any of the following underlying diseases including: - History or evidence of severe cardiac disease e.g. NYHA Functional Class III or IV (e.g. marked limitation of activity due to fatigue, palpitation or dyspnea, or worse), myocardial infarction within 6 months, ventricular tachyarrythmias requiring ongoing treatment or unstable angina. - Stroke (within 12 months of study entry) - Acute ocular or periocular infection 5. Known serious allergies to the fluorescein dye used in angiography (and indocyanine green if used) or to the components of Pegaptanib sodium formulation.

Design outcomes

Primary

Measure	Time frame
Secondary Objective: ;Primary end point(s): There are no efficacy end points;Main Objective: To provide Pegaptanib Sodium Injection to patients with subfoveal choroidal neovascularization (CNV) secondary to AMD who have previously enrolled in a Macugen study. . Patients will continue to be treated under this protocol until such time as the product becomes commercially available or the patient’s lesion is considered to have resolved or stabilized in the opinion of the treating ophthalmologist.	—

Measure

Time frame

Secondary Objective: ;Primary end point(s): There are no efficacy end points;Main Objective: To provide Pegaptanib Sodium Injection to patients with subfoveal choroidal neovascularization (CNV) secondary to AMD who have previously enrolled in a Macugen study. . Patients will continue to be treated under this protocol until such time as the product becomes commercially available or the patient’s lesion is considered to have resolved or stabilized in the opinion of the treating ophthalmologist.

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Countries

Portugal, Spain, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026