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Phase 4 N=31 Treatment

Peripheral and Macular Retinal Vascular Perfusion and Leakage in DME and RVO

Retinal Vein Occlusion · Diabetic Macular Edema · Branch Retinal Vein Occlusion · Central Retinal Vein Occlusion

Enrolled (actual)
31
Serious AEs
9.7%
Results posted
Feb 2020
Primary outcome: Primary: Change in Panretinal Leakage Index at Month 12 From Baseline — -3.14 percentage of region of interest in UWFA

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Aflibercept (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Justis Ehlers
Primary completion
Feb 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Panretinal Leakage Index at Month 12 From Baseline
-3.14
SECONDARY
Mean Change in Total Leakage Index
0.47
SECONDARY
Change in Panretinal Ischemic Index
3.2
SECONDARY
Change in Panretinal Ischemic Index From Baseline at 6 Months
0.67
SECONDARY
Mean Change From Baseline Central Subfield Thickness
301.3
SECONDARY
Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) Score Based on ETDRS
18.4
SECONDARY
Number of Participants Who Gained 15 ETDRS Letters or More of Vision
13
SECONDARY
Number of Patients Who Gained 15 ETDRS Letters or More of Vision
12
SECONDARY
Number of Patients That Showed Visual Acuity 20/40 or Better
19
SECONDARY
Number of Patients That Showed Visual Acuity 20/200 or Worse
SECONDARY
Ocular Serious Adverse Events
SECONDARY
Number of Participants Who Lost 15 ETDRS Letters or More of Vision
SECONDARY
Number of Participants Who Lost 15 ETDRS Letters or More of Vision
SECONDARY
Number of Patients That Showed Visual Acuity 20/40 or Better
19
SECONDARY
Number of Patients That Showed Visual Acuity 20/200 or Worse
SECONDARY
Mean Change From Baseline Central Subfield Thickness
301.3
SECONDARY
Systemic Serious Adverse Events
3

Summary

This interventional study will evaluate the retinal vascular dynamics associated with Intravitreal Aflibercept Injection (IAI) therapy in eyes with diabetic macular edema (DME) or macular edema secondary to retinal vein occlusion (RVO). Ultra-widefield fluorescein angiography and optical coherence tomography (OCT) angiography will be performed at multiple timepoints to assess the changes in retinal vascular leakage, ischemia, and vascular abnormalities throughout the study duration and compare these alterations to baseline.

Eligibility Criteria

Inclusion Criteria

A subject must meet the following criteria to be eligible for inclusion in the study:

  • Signed Informed Consent.
  • Men and women ≥ 18 years of age.
  • Foveal-involving retinal edema secondary to DME or RVO based on investigator review of SDOCT.
  • E-ETDRS best-corrected visual acuity of: 20/25 to 20/400 in the study eye or Hand Motion (HM) 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.

Exclusion Criteria

A subject who meets any of the following criteria will be excluded from the study:

  • Any prior or concomitant therapy with another investigational agent to treat DME or RVO 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 allergy to fluorescein sodium or other reason that the patient is unable to undergo fluorescein angiography (e.g., inability to get vascular access, unable to tolerate procedure)
  • 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.
  • Presence of other causes of macular edema, including myopic degeneration, ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, choroidal neovascularization, neovascular age-related macular degeneration or multifocal choroiditis in the study eye. Epiretinal membranes are allowed.
  • Presence of macula-threatening traction retinal detachment.
  • 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 on 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.
  • Uncontrolled glaucoma at baseline evaluation (defined as intraocular pressure ≥25 mmHg despite treatment with anti-glaucoma medication) in the study eye.
  • Active intraocular inflammation in either eye.
  • Active ocular or periocular infection in either 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 full-thickness penetrating keratoplasty in the study eye. Partial thickness corneal transplants including Descemet stripping automated endothelial keratoplasty and Descemet membrane endothelial keratoplasty are allowed.
  • 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 52 week 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02503540). 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.

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