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
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
  • Phase

    Phase 1/Phase 2
  • Study Type

    Interventional
  • Intervention/Treatment

    ranibizumab ...
  • Study Participants

    25
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.
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.
Study Started
Aug 31
2015
Primary Completion
May 31
2018
Study Completion
May 31
2018
Results Posted
Jul 08
2021
Last Update
Jul 08
2021

Drug ranibizumab 0.3mg

intravitreally administered

  • Other names: Lucentis

Diabetic macular edema treatment group (Group 1) Active Comparator

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

Diabetic macular edema and lipid treatment group (Group 2) Active Comparator

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

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

Summary

Diabetic Macular Edema Treatment Group (Group 1)

Diabetic Macular Edema and Lipid Treatment Group (Group 2)

All Events

Event Type Organ System Event Term Diabetic Macular Edema Treatment Group (Group 1) Diabetic Macular Edema and Lipid Treatment Group (Group 2)

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.

Diabetic Macular Edema Treatment Group (Group 1)

12 Months

77.92
letters read correctly (Mean)
Standard Deviation: 9.61

6 Months

78.0
letters read correctly (Mean)
Standard Deviation: 9.98

Diabetic Macular Edema Treatment Group (Group 1)

12 Months

77.92
letters read correctly (Mean)
Standard Deviation: 9.61

6 Months

78.0
letters read correctly (Mean)
Standard Deviation: 9.98

Diabetic Macular Edema and Lipid Treatment Group (Group 2)

12 Months

74.83
letters read correctly (Mean)
Standard Deviation: 8.32

6 Months

73.92
letters read correctly (Mean)
Standard Deviation: 8.40

Diabetic Macular Edema and Lipid Treatment Group (Group 2)

12 Months

74.83
letters read correctly (Mean)
Standard Deviation: 8.32

6 Months

73.92
letters read correctly (Mean)
Standard Deviation: 8.40

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

Diabetic Macular Edema Treatment Group (Group 1)

60.0
percentage of eyes

Diabetic Macular Edema Treatment Group (Group 1)

60.0
percentage of eyes

Diabetic Macular Edema and Lipid Treatment Group (Group 2)

58.0
percentage of eyes

Diabetic Macular Edema and Lipid Treatment Group (Group 2)

58.0
percentage of eyes

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

Diabetic Macular Edema Treatment Group (Group 1)

7.0
eyes

Diabetic Macular Edema Treatment Group (Group 1)

7.0
eyes

Diabetic Macular Edema and Lipid Treatment Group (Group 2)

7.0
eyes

Diabetic Macular Edema and Lipid Treatment Group (Group 2)

7.0
eyes

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

Diabetic Macular Edema Treatment Group (Group 1)

90.0
percentage of eyes

Diabetic Macular Edema Treatment Group (Group 1)

90.0
percentage of eyes

Diabetic Macular Edema and Lipid Treatment Group (Group 2)

92.0
percentage of eyes

Diabetic Macular Edema and Lipid Treatment Group (Group 2)

92.0
percentage of eyes

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

Diabetic Macular Edema Treatment Group (Group 1)

70.0
percentage of eyes

Diabetic Macular Edema Treatment Group (Group 1)

70.0
percentage of eyes

Diabetic Macular Edema and Lipid Treatment Group (Group 2)

83.0
percentage of eyes

Diabetic Macular Edema and Lipid Treatment Group (Group 2)

83.0
percentage of eyes

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

Diabetic Macular Edema Treatment Group (Group 1)

Diabetic Macular Edema Treatment Group (Group 1)

Diabetic Macular Edema and Lipid Treatment Group (Group 2)

Diabetic Macular Edema and Lipid Treatment Group (Group 2)

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

Diabetic Macular Edema Treatment Group (Group 1)

Diabetic Macular Edema and Lipid Treatment Group (Group 2)

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

Diabetic Macular Edema Treatment Group (Group 1)

Diabetic Macular Edema and Lipid Treatment Group (Group 2)

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

Diabetic Macular Edema Treatment Group (Group 1)

Diabetic Macular Edema and Lipid Treatment Group (Group 2)

Total

24
Participants

Age, Continuous

65.75
years (Mean)
Standard Deviation: 8.65

Race and Ethnicity Not Collected

0
Participants

Age, Categorical

Region of Enrollment

Sex: Female, Male

Overall Study

Diabetic Macular Edema Treatment Group (Group 1)

Diabetic Macular Edema and Lipid Treatment Group (Group 2)

Drop/Withdrawal Reasons

Diabetic Macular Edema Treatment Group (Group 1)