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Diabetic Macular EdemaPhase 4PRECISIONNCT04411693

Comparative Study of Dexamethasone Implant to Intravitreal Aflibercept in Subjects With Diabetic Macular Edema

A Phase 4 study testing Dexamethasone implant and Aflibercept in people with Diabetic Macular Edema, run by The Cleveland Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is an interventional, prospective randomized study comparing the dexamethasone implant to intravitreal aflibercept. Subjects will have an initial single injection of aflibercept and will be randomized if diabetic macular edema persists. Each subject will be evaluated for 6 months following randomization. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Diabetic Macular Edema
What is being tested?
Dexamethasone implant and Aflibercept
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
1 siteUnited States
Study dates
10 Apr 2020to 14 May 2025
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Signed Informed Consent.
  • Men and women ≥ 18 years of age.
  • Foveal-involving retinal edema secondary to DME based on investigator review of SD-OCT.
  • Central subfield thickness on SDOCT of greater than or equal to 325 microns on Spectralis or 300 microns on Cirrus.
  • E-ETDRS best-corrected visual acuity of 20/400 or better in the study eye.
  • Willing, committed, and able to return for ALL clinic visits and complete all study related procedures.
  • Able to read, (or, if unable to read due to visual impairment, be read to verbatim by the person administering the informed consent or a family member) understand and willing to sign the informed consent form.

Who cannot join

  • Any prior or concomitant therapy with another investigational agent to treat DME in the study eye.
  • Prior panretinal photocoagulation in the study eye.
  • Prior intravitreal anti-VEGF therapy in the study eye.
  • Prior focal/grid laser photocoagulation in the study eye.
  • Prior history of intravitreal steroid therapy in the study eye.
  • Any history of severe allergy to fluorescein sodium (e.g., anaphylaxis, difficulty breathing) or other reason that the patient is unable to undergo fluorescein angiography (e.g., inability to get vascular access, unable to tolerate procedure). If allergy is mild and investigator believes can be pretreated with diphenhydramine to avoid allergic response, this is not an exclusion to enrollment.
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  • Uncontrolled glaucoma at baseline evaluation (defined as intraocular pressure ≥25 mmHg despite treatment with anti-glaucoma medication) in the study eye and/or cup-to-disc ratio greater or equal to 0.8.
  • Active intraocular inflammation in either eye.
  • Active ocular or periocular infection in either eye.
  • Torn or ruptured posterior lens capsule in study eye. Laser capsulotomy is not a contraindication.
  • Prior systemic anti-VEGF therapy, investigational or FDA-approved, is only allowed up to 3 months prior to first dose, and will not be allowed during the study.
  • Significant vitreous hemorrhage obscuring view to the macula or the retinal periphery as determined by the investigator on clinical exam and ultra-widefield angiography, in study eye.
  • Presence of other causes of macular edema, including pathologic myopia (spherical equivalent of -8 diopters or more negative, or axial length of 25 mm or more), ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, choroidal neovascularization, age-related macular degeneration or multifocal choroiditis in the study eye. Epiretinal membranes are allowed.
  • Presence of macula-threatening traction retinal detachment in the study eye.
  • Prior vitrectomy in the study eye.
  • History of retinal detachment or treatment or surgery for retinal detachment in the study eye.
  • Any history of macular hole of stage 2 and above in the study eye.
  • Any intraocular or periocular surgery within 3 months of Day 1 in the study eye, except lid surgery, which may not have taken place within 1 month of day 1, as long as it's unlikely to interfere with the injection.
  • Prior trabeculectomy or other filtration surgery in the study eye.
  • Any ocular or periocular infection within the last 2 weeks prior to Screening in either eye.
  • Any history of uveitis in either eye.
  • Active scleritis or episcleritis in either eye.
  • Presence or history of scleromalacia in either eye.
  • Aphakia in the study eye.
  • Previous therapeutic radiation in the region of the study eye.
  • History of corneal transplant or corneal dystrophy in the study eye.
  • Significant media opacities, including cataract, in the study eye which might interfere with visual acuity, assessment of safety, or fundus photography.
  • Any concurrent intraocular condition in the study eye (e.g. cataract) that, in the opinion of the investigator, could require either medical or surgical intervention during the study period.
  • Any concurrent ocular condition in the study eye which, in the opinion of the investigator, could either increase the risk to the subject beyond what is to be expected from standard procedures of intraocular injection, or which otherwise may interfere with the injection procedure or with evaluation of efficacy or safety.
  • Participation as a subject in any clinical study within the 12 weeks prior to Day 1.
  • Any systemic therapy with an investigational agent in the past 3 months prior to Day 1.
  • Any history of allergy to povidone iodine.
  • Pregnant or breast-feeding women
  • Women of childbearing potential* who are unwilling to practice adequate contraception during the study (adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device [IUD]; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly) *Postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of child bearing potential. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Retina Consultants of Houston

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: Prospective Randomized Comparative Trial for Combination Dexamethasone Implant With PRN Anti-VEGF Therapy to Anti-VEGF Therapy Alone in Treatment Resistant DME: Informing the Role for Imaging Biomarkers

This study is an interventional, prospective randomized study comparing the dexamethasone implant to intravitreal aflibercept. Subjects will have an initial single injection of aflibercept and will be randomized if diabetic macular edema persists. Each subject will be evaluated for 6 months following randomization. Thus, the study duration will be 12 months plus the recruitment period.

Subjects will be evaluated every month for safety, efficacy as measured by SDOCT and best corrected visual acuity (BCVA) using the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) protocol. In addition, ultra-widefield angiography will be performed at run-in visit, baseline, month 3, and month 6.

Being tested
Dexamethasone implant, Aflibercept

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dexamethasone implantDrug

    Also called Ozurdex

    A sustained-release drug delivery system containing 0.7 mg of Dexamethasone. Implant is administered by intravitreal injection.

  • AfliberceptDrug

    Also called Eylea

    A single dose, 2mg, drug administered by intravitreal injection.

Study groups in NCT04411693
Study groupRoleWhat they receive
Group A: Intravitreal Dexamethasone ImplantActive comparatorSubjects in this arm will be given intravitreal Dexamethasone implant injection at month 0. PRN intravitreal Dexamethasone implant injections will be given for persistent edema, if it has been 10 weeks or more since last implant injection. If it has been less than 10 weeks since last implant injection, subjects will receive PRN intravitreal Aflibercept for persistent edema.
Receives: Drug: Dexamethasone implant; Drug: Aflibercept
Group B: Intravitreal AfliberceptActive comparatorSubjects in this arm will be given Intravitreal aflibercept at month 0. PRN intravitreal Aflibercept will be given at months 1-6 for persistent edema.
Receives: Drug: Aflibercept

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Mean Change in Central Subfield Thickness

    It is defined as the mean change in the thickness between the internal limiting membrane (ILM) and the retinal pigment epithelium (RPE) in the central 1mm.

    Discrepancy in total number relates to variable follow up for evaluation of change in parameter.

    Measured: 6 months

Secondary outcomes (9)

  1. Number of Injections

    Average number of Injections

    Measured: 6 months

  2. Change in BCVA

    Measured: 6 months

  3. Change in Leakage Index

    Leakage index refers to the percentage of leakage measured across the region of interest which are both evaluated using an imaging software for analysis. Greater leakage represents increased disease activity. The leakage index goes from 0-100 at any timepoint, though the change parameter shown below can be negative.

    Measured: 6 months

  4. Change in Ischemic Index

    Ischemic index represents the percentage of ischemia of the region of interest in fundus fluorescein angiography images. The range is 0-100 at each timepoint assessed. All things being equal greater ischemia corresponds to more severe disease. Given this parameter is a change between time points for this index, the number can be negative.

    Measured: 6 months

  5. Change in Microaneurysm Counts

    Microaneurysms are counted on the fluorescin angiography images. It is a count so there is not a set range though the vast majority of patients tend to fall between 0 to 2000 microaneurysms. All things being equal greater count represents more severe disease.

    Measured: 6 months

  6. Change in Ellipsoid Zone Integrity

    Change in ellipsoid zone integrity as measured by EZ-RPE volume. Reduced volume indicates increased disruption to the ellipsoid zone across the macular cube scan. The range is subject to differences between timepoints.

    Measured: 6 months

  7. Change in Intraretinal Fluid Volume

    This parameter is the total intraretinal fluid measured on the OCT imaging platform across the entire macular cube scan. It is a quantitative measure of macular edema and higher volume represents worse swelling.

    Measured: 6 months

  8. Change in DRSS

    Diabetic retinopathy severity scale (DRSS) was assessed at the screening visit and the month 6 visit using color fundus photography across both the intravitreal dexamethasone implant (Group A) and the intravitreal aflibercept group (Group B). DRSS assesses disease severity by extent of diabetic involvement in the eye from microaneurysms only (low severity) to vitreous hemorrhage and/or neovascularization of the disc (high severity). The scale using the ETDRS Steps range from 1 to 12. A higher score represents more severe diabetic disease burden. Thus a more negative change in DRSS value corresponds to a better therapeutic response.

    Measured: 6 months

  9. The Incidence and Severity of Ocular and Non-ocular Adverse Events and Serious Adverse Events

    Number of adverse events.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2020
  2. Study start10 Apr 2020
  3. Primary completion14 May 2025
  4. Study completion14 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04411693
Sponsor's protocol ID
ALLER1908JE
Acronym
PRECISION
Status last verified
Jul 2026
First submitted
20 May 2020
Last updated
29 Jul 2026
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dexamethasone implant and Aflibercept in people with Diabetic Macular Edema, run by The Cleveland Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Mean Change in Central Subfield Thickness (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04411693.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.

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