Microperimetry and Optical Coherence Tomography (OCT) With Lucentis for Diabetic Macular Edema (DME)

NCT00885794 | Unknown Phase 2

• 1 other identifier: EK 08-069-0508
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Diabetic maculopathy is the leading cause of visual impairment in the working-age population in developed countries. Diabetic macular edema can cause impaired visual acuity and so far is treated by laser, vitreous surgery, and intravitreal cortisone application. Still 50% of the cases do not respond to the treatment. Recently intraocular anti-VEGF-treatment with ranibizumab (Lucentis®, Novartis) in diabetic macular edema has proven efficacy to last over a period of 3 to 6 months. Still, the optimal dosage for those intravitreal injections still has to be found, because frequent injections are necessary. The measurement of visual acuity is inadequate to quantify in detail the visual impairment. Using the newest technology of a high-definition optical coherence tomography (Cirrus-OCT, Carl Zeiss Meditec Inc.) to determine the retinal thickness, and a miroperimetry (MP-1, Nidek Technologies) to determine retinal sensitivity, we hope to find the optimal dosage of intravitreal anti-VEGF treatment in diabetic macular edema. Study objective: To determine the dose response of 0.5mg and 1.0mg ranibizumab (Lucentis®, Novartis Pharma) intravitreal injection in subjects with resistant diabetic macular edema and evaluate safety and tolerability.

Conditions

Diabetic Macular Edema

Keywords

Clinically Significant Diabetic Macular Edema; Focal Laser; GRID-Laser; Ranibizumab; Lucentis; Microperimetry; High-Definition OCT; Randomized; Observer-Blinded; Ineffective Treatment with Focal Laser or GRID-Laser

Outcome Measures

Primary Outcomes (1)

• Retinal thickness

  at 3 months

Secondary Outcomes (8)

• Retinal sensitivity

  3, 6, and 9 months

• Distance best corrected visual acuity

  3, 6, and 9 months

• Reading best corrected visual acuity

  3, 6, and 9 months

• Intraocular pressure

  3, 6, and 9 months

• Type of diabetic macular edema

  3, 6, and 9 months

Study Arms (2)

0.5 mg Ranibizumab

EXPERIMENTAL

3 intravitreal injections of 0.5 mg Ranibizumab every 5 weeks

Drug: Ranibizumab

1.0 mg of Ranibizumab

EXPERIMENTAL

3 intravitreal injections of 1.0mg Ranibizumab every 5 weeks

Drug: Ranibizumab

Interventions

Ranibizumab DRUG

3 intravitreal injection every 5 weeks

Also known as: Lucentis

0.5 mg Ranibizumab; 1.0 mg of Ranibizumab

Eligibility Criteria

• Age: 51 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Study eye with clinically significant macular edema, for which one of the following characteristics has to be present:
• retinal thickening at or within 500µm from the center of the macula,
• hard exudates at or within 500µm from the center of the macula associated with thickening of the adjacent retina,
• a zone (\>1-disk area) or zones of retinal thickening of which any part is within 1 disk diameter from the center of the macula.
• Second line treatment after ineffective laser treatment
• Men or women with diabetes mellitus
• Only one eye per patient
• Age \> 50 years
• HbA1c \< 8%

You may not qualify if:

• Study eye with concomitant retinal or choroidal disorder other than diabetic retinopathy
• Study eye with significant central lens opacities and / or conditions that limit the view of the fundus
• poor general condition
• woman of childbearing potential, current pregnancy or breastfeeding
• Patients who are unwilling to adhere to visit examination schedules
• Evidence of macular traction or taut posterior hyloid.

Sponsors & Collaborators

• The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery: lead

Study Sites (1)

Rudolf Foundation Clinic

Vienna, Vienna, 1030, Austria

Location

MeSH Terms

Interventions

Ranibizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Ulrike Stolba, MD

  Department of Ophthalmology, Ludwig Boltzmann Institute for Retinology and Biomicroscopic Lasersurgery, Rudolf Foundation Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 20, 2009
• First Posted: April 22, 2009
• Study Start: May 1, 2008
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2012
• Last Updated: June 27, 2011

Record last verified: 2011-06

Locations

AU (1)