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

• Sponsor: University of Luebeck (Other)
• Overall Status: Completed
• CT.gov ID: NCT01269151
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Duration (Months): 42
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Age-Related Macular Degeneration; Retinal Function	Drug: Lucentis (Ranibizumab)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• 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
• Study Start Date: Oct 1, 2010
• Actual Primary Completion Date: Mar 1, 2013
• Actual Study Completion Date: Apr 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lucentis (Ranibizumab)	Drug: Lucentis (Ranibizumab); Ranibizumab Short- and Log-term Effects on Retinal Function measured by Multifocal-ERG and Microperimetry

Outcome Measures

Primary Outcome Measures

1. Changes of retinal function of the macula monitored by multifocal-ERG and microperimetry as measured 12 months. [12 months]

   Main outcome measures are the changes of retinal function of the macula monitored by multifocal-ERG and microperimetry as measured 12 months.

Secondary Outcome Measures

1. to document changes in best corrected visual acuity (BCVA) measured on 4 meters, [12 months]

   to document changes in best corrected visual acuity (BCVA) measured on 4 meters,

2. to document changes in angiography [12 months]

   to document changes in angiography

3. to document changes in optical coherence tomography (OCT) [12 months]

   to document changes in optical coherence tomography (OCT)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Luebeck - Department of Ophthalmology	Lübeck		Germany	23538

Sponsors and Collaborators

• University of Luebeck

Investigators

• Principal Investigator: Salvatore Grisanti, M.D. Prof., University of Luebeck - Department of Ophthalmology: Germany

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• University of Luebeck - Department of Ophthalmology - Germany

Publications

None provided.

• Responsible Party: Dr. Matthias Lueke, Dr. med. Matthias Lüke, University of Luebeck
• ClinicalTrials.gov Identifier: NCT01269151
• Other Study ID Numbers: LucERG-001
• First Posted: Jan 4, 2011
• Last Update Posted: Apr 8, 2015
• Last Verified: Apr 1, 2015

• Keywords provided by Dr. Matthias Lueke, Dr. med. Matthias Lüke, University of Luebeck: Age-Related Macular Degeneration; Retinal Function; multifocal-ERG; Electroretinography; microperimetry; Lucentis; Ranibizumab; longterm effects; best corrected visual acuity; BCVA
• Additional relevant MeSH terms: Macular Degeneration; Ranibizumab

Study Results

No Results Posted as of Apr 8, 2015