Clinical trial NCT02448446: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Diabetic Macular Edema
Hard Lipid Exudates
Lead sponsor: South Coast Retina Center; Carson, McBeath, Boswell, Inc.
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
name: Doheny Image Reading Center
name: The Retina Partners
First posted: 2015-05-19
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Best Corrected Visual Acuity as Measured by ETDRS at 6 and 12 Months
timeFrame: 6-12 months
Secondary outcomes:
measure: Percentage of Eyes With Improvement of Lipid Deposits in the Central Subfield as Measured on OCT and Fundus Photography
timeFrame: 12 months
measure: Percentage of Eyes With Complete Resolution of Lipid Deposits in the Central Subfield as Measured on OCT and Fundus Photography
timeFrame: 12 months
measure: Number of Eyes With Complete Resolution in the Central Subfield as Measured on OCT and Fundus Photography
timeFrame: 12 months
measure: Percentage of Eyes With Improvement in Lipid Deposits Throughout the Macular Grid as Measured by OCT and Fundus Photography
timeFrame: 12 months
measure: Percentage of Patients With Complete Resolution of Lipid Deposits Throughout the Macular Grid as Measured on OCT and Fundus Photography
timeFrame: 12 months
measure: Number of Eyes With Complete Resolution of Lipid Deposits Throughout the Macular Grid as Measured by OCT and Fundus Photography
timeFrame: 12 months
measure: Incidence and Severity of Ocular Adverse Events as a Measure of Safety and Tolerability
timeFrame: 12 months
measure: Incidence and Severity of Other Adverse Events as a Measure of Safety and Tolerability
timeFrame: 12 months
Other outcomes:
Locations:
city: Huntington Beach
country: United States
facility: South Coast Retina Center; Carson, McBeath, Boswell, Inc
state: California
city: Long Beach
country: United States
facility: South Coast Retina Center; Carson, McBeath, and Boswell, Inc
state: California
city: Santa Monica
country: United States
facility: Retina Partners
state: California
city: Torrance
country: United States
facility: South Coast Retina Center; Carson, McBeath, Boswell, Inc
state: California
Study officials:
References: