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CompletedNCT02448446Updated Jul 8, 2021Results posted

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

A Phase 1/2 interventional study of ranibizumab 0.3mg in Diabetic Macular Edema and Hard Lipid Exudates, sponsored by South Coast Retina Center; Carson, McBeath, Boswell, Inc.. Completed at 4 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-07-08.

Sponsored by South Coast Retina Center; Carson, McBeath, Boswell, Inc. · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Diabetic Macular Edema
  • Hard Lipid Exudates
03

In context

Macular Edema

841 studies on the registry are indexed under Macular Edema; 56 are open to participants now.

This study's enrollment of 25 is below the median of 50 across 619 interventional studies indexed under Macular Edema.

Browse Macular Edema studies →

Lead sponsor

This is the only study on the registry with South Coast Retina Center; Carson, McBeath, Boswell, Inc. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Subjects will be eligible if the following criteria are met:

Inclusion criteria

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

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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • Active comparator
    Diabetic macular edema treatment group (Group 1)

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

    Drug: ranibizumab 0.3mg

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

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

    Drug: ranibizumab 0.3mg

Interventions

  • Drugranibizumab 0.3mg

    intravitreally administered

    Also known as: Lucentis

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6-12 months

Secondary outcomes

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

    Time frame: 12 months

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

    Time frame: 12 months

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

    Time frame: 12 months

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

    Time frame: 12 months

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

    Time frame: 12 months

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

    Time frame: 12 months

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

    Time frame: 12 months

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

    Time frame: 12 months

07

Results

Posted Jul 8, 2021

Participant flow

Participant flow — Overall Study
MilestoneDiabetic Macular Edema Treatment Group (Group 1)Diabetic Macular Edema and Lipid Treatment Group (Group 2)
Started1312
Completed1212
Not completed10
Withdrew: Withdrawal by subject10

Outcome measures

PrimaryBest 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.

Time frame:
6-12 months
Reported as:
Mean · letters read correctly
Best Corrected Visual Acuity as Measured by ETDRS at 6 and 12 Months
letters read correctlyDiabetic Macular Edema Treatment Group (Group 1)Diabetic Macular Edema and Lipid Treatment Group (Group 2)
6 Months78 ± 9.9873.92 ± 8.40
12 Months77.92 ± 9.6174.83 ± 8.32
SecondaryPercentage of Eyes With Improvement of Lipid Deposits in the Central Subfield as Measured on OCT and Fundus Photography
Time frame:
12 months
Reported as:
Number · percentage of eyes
Percentage of Eyes With Improvement of Lipid Deposits in the Central Subfield as Measured on OCT and Fundus Photography
percentage of eyesDiabetic Macular Edema Treatment Group (Group 1)Diabetic Macular Edema and Lipid Treatment Group (Group 2)
Percentage of Eyes With Improvement of Lipid Deposits in the Central Subfield as Measured on OCT and Fundus Photography7083
SecondaryPercentage of Eyes With Complete Resolution of Lipid Deposits in the Central Subfield as Measured on OCT and Fundus Photography
Time frame:
12 months
Reported as:
Number · percentage of eyes
Percentage of Eyes With Complete Resolution of Lipid Deposits in the Central Subfield as Measured on OCT and Fundus Photography
percentage of eyesDiabetic Macular Edema Treatment Group (Group 1)Diabetic Macular Edema and Lipid Treatment Group (Group 2)
Percentage of Eyes With Complete Resolution of Lipid Deposits in the Central Subfield as Measured on OCT and Fundus Photography6058
SecondaryNumber of Eyes With Complete Resolution in the Central Subfield as Measured on OCT and Fundus Photography
Time frame:
12 months
Reported as:
Number · eyes
Number of Eyes With Complete Resolution in the Central Subfield as Measured on OCT and Fundus Photography
eyesDiabetic Macular Edema Treatment Group (Group 1)Diabetic Macular Edema and Lipid Treatment Group (Group 2)
Number of Eyes With Complete Resolution in the Central Subfield as Measured on OCT and Fundus Photography77
SecondaryPercentage of Eyes With Improvement in Lipid Deposits Throughout the Macular Grid as Measured by OCT and Fundus Photography
Time frame:
12 months
Reported as:
Number · percentage of eyes
Percentage of Eyes With Improvement in Lipid Deposits Throughout the Macular Grid as Measured by OCT and Fundus Photography
percentage of eyesDiabetic Macular Edema Treatment Group (Group 1)Diabetic Macular Edema and Lipid Treatment Group (Group 2)
Percentage of Eyes With Improvement in Lipid Deposits Throughout the Macular Grid as Measured by OCT and Fundus Photography9092
SecondaryPercentage of Patients With Complete Resolution of Lipid Deposits Throughout the Macular Grid as Measured on OCT and Fundus Photography
Time frame:
12 months
Reported as:
Number · participants
Percentage of Patients With Complete Resolution of Lipid Deposits Throughout the Macular Grid as Measured on OCT and Fundus Photography
participantsDiabetic 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 Photography00
SecondaryNumber of Eyes With Complete Resolution of Lipid Deposits Throughout the Macular Grid as Measured by OCT and Fundus Photography
Time frame:
12 months
Reported as:
Number · eyes
Number of Eyes With Complete Resolution of Lipid Deposits Throughout the Macular Grid as Measured by OCT and Fundus Photography
eyesDiabetic Macular Edema Treatment Group (Group 1)Diabetic Macular Edema and Lipid Treatment Group (Group 2)
Number of Eyes With Complete Resolution of Lipid Deposits Throughout the Macular Grid as Measured by OCT and Fundus Photography00
SecondaryIncidence and Severity of Ocular Adverse Events as a Measure of Safety and Tolerability
Time frame:
12 months
Reported as:
Count of participants · Participants
Incidence and Severity of Ocular Adverse Events as a Measure of Safety and Tolerability
ParticipantsDiabetic Macular Edema Treatment Group (Group 1)Diabetic Macular Edema and Lipid Treatment Group (Group 2)
Incidence and Severity of Ocular Adverse Events as a Measure of Safety and Tolerability04
SecondaryIncidence and Severity of Other Adverse Events as a Measure of Safety and Tolerability
Time frame:
12 months
Reported as:
Count of participants · Participants
Incidence and Severity of Other Adverse Events as a Measure of Safety and Tolerability
ParticipantsDiabetic 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 Tolerability99

Adverse events

Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Diabetic Macular Edema Treatment Group (Group 1)0/12 (0%)3/12 (25%)9/12 (75%)
Diabetic Macular Edema and Lipid Treatment Group (Group 2)0/12 (0%)2/12 (16.7%)9/12 (75%)
Most frequent serious events
Most frequent serious events
EventDiabetic Macular Edema Treatment Group (Group 1)Diabetic Macular Edema and Lipid Treatment Group (Group 2)
CysticercosisGastrointestinal disorders1/120/12
Low HemoglobinCardiac disorders1/120/12
Congestive Heart FailureCardiac disorders1/120/12
Kidney InfectionInfections and infestations1/120/12
StrokeVascular disorders0/121/12
Appendix SurgeryInfections and infestations0/121/12
Heart AttackCardiac disorders0/121/12
Most frequent other events
Showing 10 of 21
Most frequent other events
EventDiabetic Macular Edema Treatment Group (Group 1)Diabetic Macular Edema and Lipid Treatment Group (Group 2)
InfluenzaInfections and infestations0/123/12
Ear InfectionEar and labyrinth disorders0/121/12
Elevated Blood PressureBlood and lymphatic system disorders1/121/12
Decreased Liver FunctionRenal and urinary disorders0/121/12
Branch Retinal Artery OcclusionEye disorders0/121/12
HeadacheVascular disorders1/120/12
ShinglesImmune system disorders1/120/12
Elevated TriglyceridesBlood and lymphatic system disorders1/120/12
Central Retinal Vein OcclusionEye disorders1/120/12
SinusitisInfections and infestations1/120/12

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Diabetic Macular Edema Treatment Group (Group 1)Diabetic Macular Edema and Lipid Treatment Group (Group 2)Total
<=18 years000
Between 18 and 65 years8715
>=65 years459
Age, Continuous
Age, Continuous(years)Diabetic Macular Edema Treatment Group (Group 1)Diabetic Macular Edema and Lipid Treatment Group (Group 2)Total
Mean64.5 ± 8.4667 ± 8.8365.75 ± 8.65
Sex: Female, Male
Sex: Female, Male(Participants)Diabetic Macular Edema Treatment Group (Group 1)Diabetic Macular Edema and Lipid Treatment Group (Group 2)Total
Female6814
Male6410
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Diabetic Macular Edema Treatment Group (Group 1)Diabetic Macular Edema and Lipid Treatment Group (Group 2)Total
Count of participants——0
Region of Enrollment
Region of Enrollment(participants)Diabetic Macular Edema Treatment Group (Group 1)Diabetic Macular Edema and Lipid Treatment Group (Group 2)Total
United States121224
08

Study locations

4 sites
  • South Coast Retina Center; Carson, McBeath, Boswell, Inc
    Huntington Beach, California 92647, United States
  • South Coast Retina Center; Carson, McBeath, and Boswell, Inc
    Long Beach, California 90505, United States
  • Retina Partners
    Santa Monica, California 90404, United States
  • South Coast Retina Center; Carson, McBeath, Boswell, Inc
    Torrance, California 90505, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Dec 1, 2014

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 8, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02448446
Lead sponsor
South Coast Retina Center; Carson, McBeath, Boswell, Inc.
Collaborators
Genentech, Inc., Doheny Image Reading Center, The Retina Partners
Responsible party
Julie Gasperini, M.D. (Medical Doctor, South Coast Retina Center; Carson, McBeath, Boswell, Inc.) — Principal investigator
First posted
May 19, 2015
Start date
Aug 2015
Primary completion
May 2018
Completion
May 2018
Results posted
Jul 8, 2021
Last update
Jul 8, 2021
View the source record on ClinicalTrials.gov ↗

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