Ranibizumab Short- and Log-term Effects on Retinal Function in wAMD

Age-Related Macular Degeneration Clinical Trial

— LucERG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01269151
• Other study ID #: LucERG-001
• Status: Completed
• Phase: N/A
• First received: January 3, 2011
• Last updated: April 7, 2015
• Start date: October 2010
• Est. completion date: April 2014

Study information

• Verified date: April 2015
• Source: University of Luebeck
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ethics Committee of the University of Luebeck: GermanyPaul-Ehrlich-Institut (PEI): Germany
• Study type: Interventional

Clinical Trial Summary

Multifocal-electroretinoram (ERG) and microperimetry are objective criteria to asses retinal function. No information besides visual acuity exist for the development of retinal function during the course of wet AMD during therapy with Lucentis. The aim of our study is to evaluate the value of multifocal-ERG and microperimetry as an sensitive tool and early predictor of recurrence of the disease. The second goal will be to evaluate the neuroprotective effects of an adequate therapy on retinal function using microperimetry and multifocal-ERG during the course of wet AMD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2014
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

1. Male and female patients above 50 years of age

2. wet age-related macular degeneration (AMD)

3. an available follow-up of 12 months

4. written informed consent

5. visual acuity of 0.1 or better

Exclusion Criteria:

Systemic conditions or treatments

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 within the last 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

Compliance/ Administrative

1. Previous participation in any clinical studies of investigational drugs (excluding vitamins and minerals) within 1 month (or a period corresponding to 5 half-lives of the investigational drug, whatever is longer) prior to inclusion.

2. Patients will be excluded who were younger than 50 years according of the definition of age-related AMD.

3. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant.

4. Pregnant or nursing (lactating) women

5. Inability to comply with study or follow-up procedures.

6. Any treatment with an investigational agent in the past 3 months any condition.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Macular Degeneration
• Retinal Function

Intervention

Drug:
• Lucentis (Ranibizumab)
Ranibizumab Short- and Log-term Effects on Retinal Function measured by Multifocal-ERG and Microperimetry

Locations

Country	Name	City	State
Germany	University of Luebeck - Department of Ophthalmology	Lübeck

Sponsors (1)

Lead Sponsor	Collaborator
University of Luebeck

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of retinal function of the macula monitored by multifocal-ERG and microperimetry as measured 12 months.	Main outcome measures are the changes of retinal function of the macula monitored by multifocal-ERG and microperimetry as measured 12 months.	12 months	No
Secondary	to document changes in best corrected visual acuity (BCVA) measured on 4 meters,	to document changes in best corrected visual acuity (BCVA) measured on 4 meters,	12 months	No
Secondary	to document changes in angiography	to document changes in angiography	12 months	No
Secondary	to document changes in optical coherence tomography (OCT)	to document changes in optical coherence tomography (OCT)	12 months	No

External Links

•   University of Luebeck - Department of Ophthalmology - Germany