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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

Primary Purpose

Diabetic Macular Edema, Hard Lipid Exudates

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

ranibizumab 0.3mg

About this trial

This is an interventional treatment trial for Diabetic Macular Edema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

South Coast Retina Center; Carson, McBeath, Boswell, Inc
South Coast Retina Center; Carson, McBeath, and Boswell, Inc
Retina Partners
South Coast Retina Center; Carson, McBeath, Boswell, Inc

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Diabetic macular edema treatment group (Group 1)

Diabetic macular edema and lipid treatment group (Group 2)

Arm Description

Treatment using intravitreal ranibizumab 0.3mg based on the DRCR protocol I 4:2:7 strategy based on the presence of macular edema.

Continued treatment with intravitreal ranibizumab 0.3mg until, not only the macular edema is resolved, but also until the lipid exudate is resolved.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Percentage of Eyes With Improvement of Lipid Deposits in the Central Subfield as Measured on OCT and Fundus Photography

Percentage of Eyes With Complete Resolution of Lipid Deposits in the Central Subfield as Measured on OCT and Fundus Photography

Number of Eyes With Complete Resolution in the Central Subfield as Measured on OCT and Fundus Photography

Percentage of Eyes With Improvement in Lipid Deposits Throughout the Macular Grid as Measured by OCT and Fundus Photography

Percentage of Patients With Complete Resolution of Lipid Deposits Throughout the Macular Grid as Measured on OCT and Fundus Photography

Number of Eyes With Complete Resolution of Lipid Deposits Throughout the Macular Grid as Measured by OCT and Fundus Photography

Incidence and Severity of Ocular Adverse Events as a Measure of Safety and Tolerability

Incidence and Severity of Other Adverse Events as a Measure of Safety and Tolerability

Full Information

NCT ID

NCT02448446

First Posted

March 5, 2015

Last Updated

July 6, 2021

Sponsor

South Coast Retina Center; Carson, McBeath, Boswell, Inc.

Collaborators

Genentech, Inc., Doheny Image Reading Center, Retina Partners

1. Study Identification

Unique Protocol Identification Number

NCT02448446

Brief Title

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

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Completed

Study Start Date

August 2015 (undefined)

Primary Completion Date

May 2018 (Actual)

Study Completion Date

May 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

South Coast Retina Center; Carson, McBeath, Boswell, Inc.

Collaborators

Genentech, Inc., Doheny Image Reading Center, Retina Partners

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Macular Edema, Hard Lipid Exudates

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Diabetic macular edema treatment group (Group 1)

Arm Type

Active Comparator

Arm Description

Treatment using intravitreal ranibizumab 0.3mg based on the DRCR protocol I 4:2:7 strategy based on the presence of macular edema.

Arm Title

Diabetic macular edema and lipid treatment group (Group 2)

Arm Type

Active Comparator

Arm Description

Continued treatment with intravitreal ranibizumab 0.3mg until, not only the macular edema is resolved, but also until the lipid exudate is resolved.

Intervention Type

Drug

Intervention Name(s)

ranibizumab 0.3mg

Other Intervention Name(s)

Lucentis

Intervention Description

intravitreally administered

Primary Outcome Measure Information:

Title

Best Corrected Visual Acuity as Measured by ETDRS at 6 and 12 Months

Description

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.

Time Frame

6-12 months

Secondary Outcome Measure Information:

Title

Percentage of Eyes With Improvement of Lipid Deposits in the Central Subfield as Measured on OCT and Fundus Photography

Time Frame

12 months

Title

Percentage of Eyes With Complete Resolution of Lipid Deposits in the Central Subfield as Measured on OCT and Fundus Photography

Time Frame

12 months

Title

Number of Eyes With Complete Resolution in the Central Subfield as Measured on OCT and Fundus Photography

Time Frame

12 months

Title

Percentage of Eyes With Improvement in Lipid Deposits Throughout the Macular Grid as Measured by OCT and Fundus Photography

Time Frame

12 months

Title

Percentage of Patients With Complete Resolution of Lipid Deposits Throughout the Macular Grid as Measured on OCT and Fundus Photography

Time Frame

12 months

Title

Number of Eyes With Complete Resolution of Lipid Deposits Throughout the Macular Grid as Measured by OCT and Fundus Photography

Time Frame

12 months

Title

Incidence and Severity of Ocular Adverse Events as a Measure of Safety and Tolerability

Time Frame

12 months

Title

Incidence and Severity of Other Adverse Events as a Measure of Safety and Tolerability

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

South Coast Retina Center; Carson, McBeath, Boswell, Inc

City

Huntington Beach

State/Province

California

ZIP/Postal Code

92647

Country

United States

Facility Name

South Coast Retina Center; Carson, McBeath, and Boswell, Inc

City

Long Beach

State/Province

California

ZIP/Postal Code

90505

Country

United States

Facility Name

Retina Partners

City

Santa Monica

State/Province

California

ZIP/Postal Code

90404

Country

United States

Facility Name

South Coast Retina Center; Carson, McBeath, Boswell, Inc

City

Torrance

State/Province

California

ZIP/Postal Code

90505

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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