Phase 2
Completed N=25
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 · Hard Lipid Exudates
Source: ClinicalTrials.gov NCT02448446 ↗
Enrolled (actual)
25
Serious AEs
20.8%
Results posted
Jul 2021
Primary outcomePrimary: Best Corrected Visual Acuity as Measured by ETDRS at 6 and 12 Months — 78; 73.92; 77.92; 74.83 letters read correctly
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Best Corrected Visual Acuity as Measured by ETDRS at 6 and 12 Months |
78; 73.92; 77.92; 74.83 | — |
| SECONDARY Percentage of Eyes With Improvement of Lipid Deposits in the Central Subfield as Measured on OCT and Fundus Photography |
70; 83 | — |
| SECONDARY Percentage of Eyes With Complete Resolution of Lipid Deposits in the Central Subfield as Measured on OCT and Fundus Photography |
60; 58 | — |
| SECONDARY Number of Eyes With Complete Resolution in the Central Subfield as Measured on OCT and Fundus Photography |
7; 7 | — |
| SECONDARY Percentage of Eyes With Improvement in Lipid Deposits Throughout the Macular Grid as Measured by OCT and Fundus Photography |
90; 92 | — |
| SECONDARY Percentage of Patients With Complete Resolution of Lipid Deposits Throughout the Macular Grid as Measured on OCT and Fundus Photography |
0; 0 | — |
| SECONDARY Number of Eyes With Complete Resolution of Lipid Deposits Throughout the Macular Grid as Measured by OCT and Fundus Photography |
0; 0 | — |
| SECONDARY Incidence and Severity of Ocular Adverse Events as a Measure of Safety and Tolerability |
0; 4 | — |
| SECONDARY Incidence and Severity of Other Adverse Events as a Measure of Safety and Tolerability |
9; 9 | — |
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
Data sourced from ClinicalTrials.gov (NCT02448446). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.