"A prospective, non-randomized, mono-center, cohort study to evaluate the short- and long-term effects of 0.5mg intraocular Ranibizumab (Lucentis) injections on retinal function in patients with wet age-related macular degeneration during twelve month" - Ranibizumab short- and long-term effects on retinal function in wAMD

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-021777-37-DE

Enrollment

Registered

2010-08-09

Start date

2010-09-27

Completion date

Unknown

Last updated

2020-11-09

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

Conditions

Retinal function in patients with wet age-related macular degeneration MedDRA version: 12.1 Level: LLT Classification code 10067791 Term: Wet macular degeneration

Interventions

Trade Name: Lucentis 10 mg/ml Injektionslösung Product Name: Lucentis Pharmaceutical Form: Solution for injection INN or Proposed INN: RANIBIZUMAB CAS Number: 347396-82-1 Concentration unit: mg/ml mil

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. wet age-related macular degeneration (AMD) 2. an available follow-up of 12 months 3. written informed consent 4. visual acuity of 0.1 or better 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: 1. history or evidence of severe cardiac disease (e.g., NYHA functional class III or IV) 2. clinical or medical history of unstable angina, acute coronary syndrome, myocardial infarction or revascularization with 6 months 3. ventricular tachyarrythmias requiring ongoing treatment 4. History or evidence clinically significant peripheral vascular disease, such as intermittent claudication or prior amputation 5. Clinically significant impaired renal or hepatic function 6. Stroke within 12 month before trial entry. 7. Known serious allergies to the fluorescein dye use in angiography 8. Known contraindications to the components of Lucentis® formulation. Ocular concomitant conditions/ diseases 1. Active intraocular inflammation (grade trace or above) in either eye 2. Any active infection (e.g. conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis) in either eye 3. History of uveitis in either eye 4. Treatment with anti-angiogenic drugs (pegaptanib sodium, anecortave acetate,bevacizumab, etc.) or intravitreal corticosteroids in either eye within 3 months prior to inclusion 5. Angle block glaucoma 6. Phthisis 7. Intraocular Pressure <10mmHg 8. Macular or retinal dystrophies

Design outcomes

Primary

Measure	Time frame
Main Objective: Main outcome measures are the changes of retinal function of the macula monitored by multifocal-ERG and microperimetry as measured 12 months. ;Secondary Objective: Secondary objectives are • to document changes in best corrected visual acuity (BCVA) measured on 4 meters, • to document changes in angiography • to document changes in optical coherence tomography (OCT) ;Primary end point(s): Main outcome measures are the changes of retinal function of the macula monitored by multifocal-ERG and microperimetry as measured 12 months.	—

Measure

Time frame

Main Objective: Main outcome measures are the changes of retinal function of the macula monitored by multifocal-ERG and microperimetry as measured 12 months. ;Secondary Objective: Secondary objectives are • to document changes in best corrected visual acuity (BCVA) measured on 4 meters, • to document changes in angiography • to document changes in optical coherence tomography (OCT) ;Primary end point(s): Main outcome measures are the changes of retinal function of the macula monitored by multifocal-ERG and microperimetry as measured 12 months.

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Countries

Germany

Outcome results

None listed

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