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Intravitreal Aflibercept as Indicated by Real-Time Objective Imaging to Achieve Diabetic Retinopathy Improvement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03531294
Recruitment Status : Completed
First Posted : May 21, 2018
Last Update Posted : May 21, 2021
Sponsor:
Collaborators:
Regeneron Pharmaceuticals
The Cleveland Clinic
Information provided by (Responsible Party):
Greater Houston Retina Research

Brief Summary:
The PRIME trial will assess the safety of 2 mg intravitreal aflibercept injections (IAI) to achieve and maintain DRSS improvements (2 or more steps) in patients with a baseline DRSS level of 47A to 71A inclusive through 104 weeks as determined by reading center determined DRSS gradings on OPTOS fundus photos and leakage index on OPTOS WF-FA.

Condition or disease Intervention/treatment Phase
Diabetic Retinopathy Drug: Aflibercept Injection Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intravitreal Aflibercept as Indicated by Real-Time Objective Imaging to Achieve Diabetic Retinopathy Improvement
Actual Study Start Date : May 23, 2018
Actual Primary Completion Date : April 9, 2021
Actual Study Completion Date : April 9, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1
Treatment based on central reading center reading evaluation of DRSS (diabetic retinopathy severity scale) level based on OPTOS funds photos.
Drug: Aflibercept Injection
intravitreal 2mg aflibercept injection
Other Name: Eyela

Experimental: Group 2
Treatment based on central reading center reading evaluation of DRSS (diabetic retinopathy severity scale) level based leakage index of OPTOS wide field fluorescein angiography.
Drug: Aflibercept Injection
intravitreal 2mg aflibercept injection
Other Name: Eyela




Primary Outcome Measures :
  1. Incidence of Adverse Events for diabetic retinopathy subjects who receive intravitreal Aflibercept [ Time Frame: 104 weeks ]
    Assess the safety of 2 mg intravitreal aflibercept injections (IAI) to achieve and maintain DRSS improvements (2 or more steps) in patients with a baseline DRSS level of 47A to 71A inclusive as determined by reading center determined DRSS gradings on OPTOS fundus photos and leakage index on OPTOS WF-FA


Secondary Outcome Measures :
  1. Correlation of DRSS and leakage index [ Time Frame: 104 weeks ]
    Correlation of reading-center determined DRSS level and leakage index to determine change in DR severity

  2. Correlation between Reading Center DRSS Level and Physician determined DR severity [ Time Frame: 104 weeks ]
    Correlation of reading-center determined DRSS level and investigator-determined DR severity level based on ophthalmoscopic fundus examination (Physician determined DR severity level will be based on AAO (American Academy of Ophthalmology) simplified grading system: mild NPDR, moderate NPDR, Severe NPDR, low risk PDR, high risk PDR)

  3. Number of IAI [ Time Frame: 104 weeks ]
    Mean and Median number of IVT aflibercept Injections (with and without IAI given for DME)

  4. Mean number of IAI (NPDR VS PDR) [ Time Frame: 104 weeks ]
    Mean number of IVT aflibercept Injections in eyes with baseline NPDR vs PDR through week 52

  5. ETDRS-BCVA change [ Time Frame: 104 weeks ]
    Mean change in Early Treatment Diabetic Retinopathy Study best corrected visual acuity (ETDRS-BCVA)

  6. Changes in Visual Function [ Time Frame: 104 weeks ]
    Changes in visual function outcomes as measured by National Eye Institute Visual Functioning Questionnaire (NEI-VFQ)

  7. DRSS Change [ Time Frame: 104 weeks ]
    Changes in DRSS

  8. Change in Non-Perfusion [ Time Frame: 104 weeks ]
    Change in area of retinal non-perfusion within the macula and periphery

  9. Change in Vascular Leakage [ Time Frame: 104 weeks ]
    Change in relative area of vascular leakage on wide-field fluorescein angiography

  10. Change in microaneurysms [ Time Frame: 104 weeks ]
    Change in number of microaneurysms, assessed by wide-field fluorescein angiography

  11. Change in CST [ Time Frame: 104 weeks ]
    Mean change in central subfield thickness (CST), as assessed by spectral Domain Optical coherence tomography (SD-OCT)

  12. DME development [ Time Frame: 104 weeks ]
    Percentage of subjects, who develop center-involving diabetic macular edema necessitating treatment compared to baseline

  13. PDR Development [ Time Frame: 104 weeks ]
    Percentage of subjects, who develop a new PDR event compared to baseline

  14. Cytokine Levels [ Time Frame: 104 weeks ]
    Corelation of cytokine levels in aqueous humor samples to clinical and imaging outcomes



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men or Women > 18 years of age with type 1 or II diabetes mellitus
  2. Diabetic Retinopathy, DRSS Level 47A to 71A, as assessed by CRC (enrollment of PDR levels will be limited to 50% of the total population)
  3. BCVA in the study eye better than 20/800

Exclusion Criteria:

  1. Any prior systemic anti-VEGF treatment or IVT anti-search vascular endothelial growth factor (VEGF) treatment in the study eye within 24 weeks of screening/baseline
  2. Any intravitreal or peribulbar corticosteroids in the study eye within 12 weeks of screening/baseline
  3. Any prior treatment with Ozurdex or Iluvien in the study eye
  4. SD-OCT central subfield thickness (CST) > 320 µm in the study eye
  5. Central DME causing visual acuity loss, in which treatment can not be safely deferred for at least 6 months, in the investigator's judgment
  6. Current visually significant vitreous hemorrhage in the study eye. Vitreous hemorrhage is allowed as long as DRSS level is 71A or lower.
  7. History of panretinal photocoagulation (PRP) in the study eye
  8. History of vitrectomy surgery in the study eye
  9. Cataract surgery in the study eye within 8 weeks of screening/baseline
  10. Pregnant or breast-feeding women
  11. Sexually active men* or women of childbearing potential** who are unwilling to practiceadequate 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/baseline; intrauterine device [IUD]; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly).

    * Contraception is not required for men with documented vasectomy.

    ** Postmenopausal women must be amenorrheic for at least 52 weeks in order not to be considered of childbearing potential. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.

  12. If currently receiving diaylisis, must have started treatment more than 12 weeks prior to screening/baseline
  13. Uncontrolled blood pressure (defined as > 190/110 mm Hg systolic/diastolic, while seated)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03531294


Locations
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United States, Texas
Retina Consultants of Houston/The Medical Center
Houston, Texas, United States, 77030
Retina Consultants of Houston
The Woodlands, Texas, United States, 77384
Sponsors and Collaborators
Greater Houston Retina Research
Regeneron Pharmaceuticals
The Cleveland Clinic
Additional Information:
Publications:
Wang K, Srivastava SK, Vasanji A, Hu M, Reese J, Stiegel L, and Ehlers JP. "Quantitative ultrawidefield fluorescein angiography and volumetric optical coherence tomography analysis in the REACT Study: A prospective randomized comparative dosage trial evaluating ranibizumab in bevacizumab-resistant diabetic macular edema." Scientific Poster. ARVO Annual Meeting. Baltimore, MD. May 2017.
Ehlers JP. "Peripheral and Macular Retinal Vascular Dynamics in DME and RVO Following Aflibercept Therapy: The PERMEATE Study 6-month Results" Scientific presentation. ASRS Annual Meeting. Boston, MA. August 201

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Responsible Party: Greater Houston Retina Research
ClinicalTrials.gov Identifier: NCT03531294    
Other Study ID Numbers: PRIME
First Posted: May 21, 2018    Key Record Dates
Last Update Posted: May 21, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Aflibercept
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents