Intravitreal ranibizumab in patients with retinal pigment epithelial detachments secondary to AMD

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-004675-22-DE

Enrollment

Registered

2008-09-03

Start date

2008-10-21

Completion date

Unknown

Last updated

2021-04-05

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

Conditions

Pigment epithelial detachments secondary to age-relatedmacular degeneration MedDRA version: 9.1 Level: LLT Classification code 10064930 Term: Age-related macular degeneration

Interventions

Trade Name: Lucentis Product Name: Lucentis Product Code: RFB002 Pharmaceutical Form: Solution for injection INN or Proposed INN: ranibizumab Current Sponsor code: AMD-PED08 Other descriptive name: RF

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - patients with AMD and serous PED as determined by fluoresceine and indocyaningreen angiography and optical coherence tomography (OCT) - patients who have a BCVA score between 73 and 24 ETDRS letters - patients with PED = 200 µm as determined by OCT - male or female patients 50 years of age or greater - patients willing and able to comply with all study procedures Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - patients with BCVA 73 letters in the study eye - patients previously treated by intravitreal injections of steroids or anti-VEGF agents, or patients previously treated by Verteporfin photodynamic therapy or focal laser photocoagulation - history of uncontrolled glaucoma in the study eye

Design outcomes

Primary

Measure	Time frame
Main Objective: - to demonstrate the efficacy of ranibizumab in patients with retinal pigment epithelial detachment secondary to AMD;Secondary Objective: - to evaluate the safety of ranibizumab in patients with retinal pigment epithelial detachment secondary to AMD - to evaluate the effect of ranibizumab on the change in visual function as assessed by the mean change in BCVA from Baseline - to evaluate the effect of ranibizumab on retinal structure as assessed by mean and percent change in retinal thickness and height of PED, as measured by spectral-domain optical coherence tomography - to evaluate the effect of ranibizumab on central visual field and stability of fixation as determined by NIDEK MP-1 microperimetry - to evaluate the effect of ranibizumab as assessed by the incidence of fluorescein leakage and changes in autofluorescence ;Primary end point(s): - Best-corrected visual acuity (ETDRS-charts) - PED height (OCT)	—

Measure

Time frame

Main Objective: - to demonstrate the efficacy of ranibizumab in patients with retinal pigment epithelial detachment secondary to AMD;Secondary Objective: - to evaluate the safety of ranibizumab in patients with retinal pigment epithelial detachment secondary to AMD - to evaluate the effect of ranibizumab on the change in visual function as assessed by the mean change in BCVA from Baseline - to evaluate the effect of ranibizumab on retinal structure as assessed by mean and percent change in retinal thickness and height of PED, as measured by spectral-domain optical coherence tomography - to evaluate the effect of ranibizumab on central visual field and stability of fixation as determined by NIDEK MP-1 microperimetry - to evaluate the effect of ranibizumab as assessed by the incidence of fluorescein leakage and changes in autofluorescence ;Primary end point(s): - Best-corrected visual acuity (ETDRS-charts) - PED height (OCT)

—

Countries

Germany

Outcome results

None listed

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