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A phase IV non-randomized, uncontrolled, open-label, single-center trial to evaluate the safety and efficacy of Macugen (pegaptanib sodium) given by intravitreal injections every 6 weeks in patients with serous pigment epithel detachments (PED) in exudative age-related macular degeneration (AMD)

A phase IV non-randomized, uncontrolled, open-label, single-center trial to evaluate the safety and efficacy of Macugen (pegaptanib sodium) given by intravitreal injections every 6 weeks in patients with serous pigment epithel detachments (PED) in exudative age-related macular degeneration (AMD)

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-006312-30-HU
Enrollment
30
Registered
2007-01-25
Start date
2007-04-05
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

neovascular (wet) age-related macular degeneration (AMD) MedDRA version: 8.1 Level: LLT Classification code 10025411 Term: Macular degeneration senile

Interventions

Trade Name: Macugen Pharmaceutical Form: Injection*

Sponsors

Dept. of Ophthalmol, Semmelweis University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: • Patients of either gender • Age: 50 years or above • diagnosed with early lesions of serous pigment epithel detachments secondary to AMD Early lesion defined as: • best corrected visual acuity >= 20/100, • detachments measuring =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patients with prior treatment with PDT, or subfoveal laser and with clinically significant concomitant diseases will be excluded.

Design outcomes

Primary

MeasureTime frame
Main Objective: The purpose of the study is to evaluate the safety and efficacy of Macugen in a special subgroup of AMD patients.;Secondary Objective: ;Primary end point(s): proportion of patients losing <15 letters of distance visual acuity (ETDRS) at 54 weeks—

Countries

Hungary

Outcome results

None listed

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