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

NCT03531294 | Completed Phase 2 FDA Drug

• 1 other identifier: PRIME
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetic Retinopathy

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events for diabetic retinopathy subjects who receive intravitreal Aflibercept

  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

  104 weeks

Secondary Outcomes (14)

• Correlation of DRSS and leakage index

  104 weeks

• Correlation between Reading Center DRSS Level and Physician determined DR severity

  104 weeks

• Number of IAI

  104 weeks

• Mean number of IAI (NPDR VS PDR)

  104 weeks

• ETDRS-BCVA change

  104 weeks

Study Arms (2)

Group 1

EXPERIMENTAL

Treatment based on central reading center reading evaluation of DRSS (diabetic retinopathy severity scale) level based on OPTOS funds photos.

Drug: Aflibercept Injection

Group 2

EXPERIMENTAL

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

Interventions

Aflibercept Injection DRUG

intravitreal 2mg aflibercept injection

Also known as: Eyela

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• Any intravitreal or peribulbar corticosteroids in the study eye within 12 weeks of screening/baseline
• Any prior treatment with Ozurdex or Iluvien in the study eye
• SD-OCT central subfield thickness (CST) \> 320 µm in the study eye
• Central DME causing visual acuity loss, in which treatment can not be safely deferred for at least 6 months, in the investigator's judgment
• Current visually significant vitreous hemorrhage in the study eye. Vitreous hemorrhage is allowed as long as DRSS level is 71A or lower.
• History of panretinal photocoagulation (PRP) in the study eye
• History of vitrectomy surgery in the study eye
• Cataract surgery in the study eye within 8 weeks of screening/baseline
• Pregnant or breast-feeding women
• 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.
• If currently receiving diaylisis, must have started treatment more than 12 weeks prior to screening/baseline
• Uncontrolled blood pressure (defined as \> 190/110 mm Hg systolic/diastolic, while seated)

Sponsors & Collaborators

• Greater Houston Retina Research: lead
• Regeneron Pharmaceuticals: collaborator
• The Cleveland Clinic: collaborator

Study Sites (2)

Retina Consultants of Houston/The Medical Center

Houston, Texas, 77030, United States

Location

Retina Consultants of Houston

The Woodlands, Texas, 77384, United States

Location

Related Publications (31)

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Related Links

• World Helath Organization (WHO). Global Report on Diabetes. 2016
• 2016 America Society of Retina Specialists Preferences and Trends Survey

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2018
• First Posted: May 21, 2018
• Study Start: May 23, 2018
• Primary Completion: April 9, 2021
• Study Completion: April 9, 2021
• Last Updated: May 21, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)