Change Oxygen Consumption Following Intravitreal Treatment of Lucentis (Ranibizumab) in Eyes With Diabetic Macular Edema

NCT02329132 | Completed

• 1 other identifier: H26-000
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Recent reports suggest that anti-VEGF agents (ranibizumab) may suppress the progression of retinal nonperfusion area. This protective effect would cause the increase of the oxygen consumption in the diabetic retina. We expect that the current study using the retinal oximetry would show the protective effects of ranibizumab on the hypoxia in the diabetic retina. This study is designed to analyze the effects of ranibizumab (Lucentis) to the retinal oxygen saturation or consumption in eyes with diabetic macular edema.

Conditions

Diabetic Macular Edema

Keywords

diabetic macular edema; VEGF; ranibizumab; oxygen consumption

Outcome Measures

Primary Outcomes (1)

• The change of retinal oxygen saturation and consumption from baseline at 6 months

  Retinal oximetry will be performed with Oxymap (Oxymap ehf, Reykjavik, Iceland). Briefly, the device simultaneously acquires digital images at two wavelengths and automatically tracks retinal vessels on both images. Retinal vessel oxygen saturation is estimated by spectrophotometric analysis of light reflected from retinal vessels and from the immediately surrounding retina. Oxygen saturation measurements are made on major temporal arteries and veins. Briefly, the first and second degree vessels are used, with the addition of third degree vessels in images where peripapillary haemorrhage prevented analysis close to the optic disc. Vessel segments chosen for analysis are used consistently for consecutive measurements in the same retina. Oxygen saturation measurements will be measured at each visit for 6 months.

  At 6 months after ranibizumab (Lucentis) treatment.

Interventions

Ranibizumab DRUG

Each eye will be treated with three initial monthly injections of intravitreal ranibizumab 0.5 mg (Lucentis), followed by retreatment as needed, guided by monthly clinical examinations including biomicroscopy, VA measurement, and optical coherence tomography (OCT) examination.

Also known as: Lucentis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Diabetic macular edema involving the foveal center, who are planned to be treated with intravitreal injections of ranibizumab.

You may qualify if:

• Diabetic macular edema involving the foveal center
• Male or female of aged 18 years or older
• Decrease of visual acuity (VA) due to macular edema
• Signed informed consent form

You may not qualify if:

• Previous treatment with anti-VEGF drugs or corticosteroid or grid laser photocoagulation
• Ocular disorders in the study eye that may confound interpretation of study results
• History of vitrectomy surgery, or other surgical intervention other than the cataract surgery
• The pregnant or lactating woman

Sponsors & Collaborators

• Kagawa University: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (1)

Kagawa University Faculty of Medicine

Hiragi, Kagawa-ken, 761-0793, Japan

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Aqueous humor is obtained at the initial injection of Lucentis.

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

• AKITAKA TSUJIKAWA, MD

  Kagawa Univerisity Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chairman

Study Record Dates

• First Submitted: December 26, 2014
• First Posted: December 31, 2014
• Study Start: November 1, 2015
• Primary Completion: January 28, 2018
• Study Completion: February 28, 2018
• Last Updated: March 8, 2018

Record last verified: 2018-03

Locations

JP (1)