The Effect of Intravitreal Ranibizumab on Visual Acuity and Hard Exudate Resolution in the Treatment of Diabetic Macular Edema With Center Involved Edema and Lipid Exudates

Diabetic Macular Edema Clinical Trial

Official title:

The Effect of Intravitreal Ranibizumab on Visual Acuity and Hard Exudate Resolution in the Treatment of Diabetic Macular Edema With Foveal Involving Edema and Lipid Exudates

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02448446
• Other study ID #: ML259577
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: August 2015
• Est. completion date: May 2018

Study information

• Verified date: July 2021
• Source: South Coast Retina Center; Carson, McBeath, Boswell, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an open-label, Phase I/II study of intravitreally administered 0.3mg ranibizumab in subjects with diabetic macular edema and lipid exudates in the central subfield.

Description:

This is an open-label, Phase I/II study of intravitreally administered 0.3mg ranibizumab in subjects with diabetic macular edema and lipid exudates in the central subfield.

Consented, enrolled subjects will receive multiple open-label intravitreal injections on 0.3mg ranibizumab administered every 30 days for 12 months per the treatment algorithm.

The patients will be randomized to 1 of 2 treatment groups. Group 1: Treatment algorithm based on the Diabetic Retinopathy Clinical Research (DRCR) protocol I 4:2:7 strategy based on the presence of macular edema.

Group 2: Continue treatment until not only the macular edema is resolved but also until the lipid exudate is resolved.

Sample size: 30 eyes Follow-up Schedule: Every 4 weeks throughout the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Subjects will be eligible if the following criteria are met:

Inclusion Criteria

• Ability to provide written informed consent and comply with study assessments for the full duration of the study

• Age = 18 years

• Type 1 or Type 2 Diabetes mellitus

• Best corrected ETDRS visual acuity (20/32-20/320) or letter score 78 to 24

• Diabetic macular edema on clinical examination involving the center of the macula assessed to be the main cause of visual loss

• Retinal thickness measured on spectral domain optical coherence tomography (OCT). Zeiss Cirrus: =290µm in women and =305 µm in men in the central subfield. Heidelberg Spectralis: =305µm in women and =320 µm in men in the central subfield

• Lipid exudates involving the central subfield on spectral domain OCT.

Exclusion Criteria

Subjects who meet any of the following criteria will be excluded from this study:

• Treatment for diabetic macular edema within the prior 4 months.

• Panretinal photocoagulation within the prior 4 months or anticipated need for panretinal photocoagulation within the next 6 months

• major ocular surgery within the prior 4 months

• myocardial infarction, other cardiac event requiring hospitalization, cerebrovascular accident, transient ischemic attack, or treatment for acute congestive heart failure occurred within 4 months before randomization

• Pregnancy (positive pregnancy test) or lactation

• Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an intrauterine device (IUD), or contraceptive hormone implant or patch.

• Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated

• Participation in another simultaneous medical investigation or trial

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Hard Lipid Exudates
• Macular Edema

Intervention

Drug:
• ranibizumab 0.3mg
intravitreally administered

Locations

Country	Name	City	State
United States	South Coast Retina Center; Carson, McBeath, Boswell, Inc	Huntington Beach	California
United States	South Coast Retina Center; Carson, McBeath, and Boswell, Inc	Long Beach	California
United States	Retina Partners	Santa Monica	California
United States	South Coast Retina Center; Carson, McBeath, Boswell, Inc	Torrance	California

Sponsors (4)

Lead Sponsor	Collaborator
South Coast Retina Center; Carson, McBeath, Boswell, Inc.	Doheny Image Reading Center, Genentech, Inc., Retina Partners

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best Corrected Visual Acuity as Measured by ETDRS at 6 and 12 Months	Compare Group 1 and Group 2 for best correct visual acuity (BCVA), as assessed by the number of letters read correctly on the ETDRS eye chart at a starting test distance of 4 meters.	6-12 months
Secondary	Percentage of Eyes With Improvement of Lipid Deposits in the Central Subfield as Measured on OCT and Fundus Photography		12 months
Secondary	Percentage of Eyes With Complete Resolution of Lipid Deposits in the Central Subfield as Measured on OCT and Fundus Photography		12 months
Secondary	Number of Eyes With Complete Resolution in the Central Subfield as Measured on OCT and Fundus Photography		12 months
Secondary	Percentage of Eyes With Improvement in Lipid Deposits Throughout the Macular Grid as Measured by OCT and Fundus Photography		12 months
Secondary	Percentage of Patients With Complete Resolution of Lipid Deposits Throughout the Macular Grid as Measured on OCT and Fundus Photography		12 months
Secondary	Number of Eyes With Complete Resolution of Lipid Deposits Throughout the Macular Grid as Measured by OCT and Fundus Photography		12 months
Secondary	Incidence and Severity of Ocular Adverse Events as a Measure of Safety and Tolerability		12 months
Secondary	Incidence and Severity of Other Adverse Events as a Measure of Safety and Tolerability		12 months