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The IAI-OCTA Study; a Study of OCT-Angiography Analysis Efficacy (IAI-OCTA)

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ClinicalTrials.gov Identifier: NCT03022292
Recruitment Status : Recruiting
First Posted : January 16, 2017
Last Update Posted : December 24, 2018
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
David Sarraf, MD, University of California, Los Angeles

Brief Summary:

A study investigating the ability of OCTA imaging technology to identify and analyze untreated type 1, 2, and 3 neovascular membrane lesions in treatment naive patients with exudative macular degeneration, as well as investigating the ability of the OCTA imaging technology to evaluate the treatment outcomes of Intravitreal Aflibercept Injection in neovascular lesions associated with macular degeneration.

This study is utilizing a new, FDA approved, non-standard of care technology (OCT-Angiography by Optovue) to image and evaluate the treatment outcomes of using standard of care Intravitreal Aflibercept Injections for their approved use in patients diagnosed with neovascular AMD who are naive to previous Anti-VEGF therapies.


Condition or disease Intervention/treatment Phase
Wet Macular Degeneration Drug: Aflibercept Ophthalmic Device: optovue angiovue Phase 4

Detailed Description:

Prospective study of neovascular AMD subjects with type 1, 2, or 3 neovascularization that have not been treated with prior anti-VEGF therapy. Subjects will be scheduled for intravitreal aflibercept injection (IAI) at baseline, week 4, week 8, week 16, week 24, week 36, and week 48. Additional injections can be administered during the remaining visits on an as needed basis per PI discretion based on the presence of any intraretinal or subretinal fluid on OCT, heme visualized on examination, reduction of BCVA by 5 or more ETDRS letters, or evidence of either increased area, density, or activity of the brush border of the neovascularization on OCT angiography. There will be a minimum of 21 days between subsequent injections. Each subject will therefore receive a minimum of 7 injections and up to a maximum of 13 injections throughout the study period. No injection will be given on the exit visit, week 52. OCT angiography and spectral domain OCT imaging will be performed at baseline and every 4 weeks thereafter

The above procedures are standard of care for neovascular AMD subjects.

As part of this study, these subjects will also undergo imaging of both eyes with OCTA at each visit. This is not standard of Care and is research.

The only procedure that is being performed for research is the OCT-A. The injections and all other procedure are SOC based on physician discretion and clinical need. The investigators will not be modifying the dosage amounts or frequency.

A subgroup of willing subjects will undergo OCT angiography every 2 weeks for the first 12 weeks.

Indocyanine green angiography will be performed at baseline for all subjects to establish baseline subject population characteristics. Fluorescein angiography will be performed at baseline, week 12, and week 52 for efficacy monitoring. Detailed OCT angiography analysis will be performed to identify anatomical and morphological biomarkers of growth progression and disease activity. In addition to qualitative structural and morphological analysis, detailed quantitative OCT angiography analysis of the neovascular lesion using automated or manual capillary density maps and area calculation will be performed at each visit to determine the detailed microvascular response of neovascular complexes to IAI therapy.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The IAI-OCTA Study or; Microvascular Structure and Morphology of Neovascular Membranes in Age Related Macular Degeneration (AMD) After Intravitreal Aflibercept Injection (IAI) Therapy Using OCT-Angiography Analysis
Actual Study Start Date : March 30, 2017
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Aflibercept

Arm Intervention/treatment
Experimental: IAI Treatment
Intravitreal injection of aflibercept 2 mg/0.05 ml at baseline, week 4, week 8, week 16, week 24, week 36, and week 48. Additional injections can be administered during the remaining visits on an as needed basis per Primary Investigator (PI) discretion based on the presence of any intraretinal or subretinal fluid on OCT, heme visualized on examination, reduction of BCVA by 5 or more ETDRS letters, or evidence of either increased area, density, or activity of the brush border of the neovascularization on OCT-angiography. There will be a minimum of 21 days between subsequent injections. Each subject will therefore receive a minimum of 7 injections and up to a maximum of 13 injections throughout the study period.
Drug: Aflibercept Ophthalmic
IAI given for active exudative macular degeneration (CNV, SRF, PED) per SOC

Device: optovue angiovue
FDA approved Optovue Angiovue will be used to monitor progression and responsiveness of active exudative macular degeneration to IAI.
Other Name: OCTA




Primary Outcome Measures :
  1. OCTA Analysis of lesion area [ Time Frame: Week 24 and 52 ]
    OCT angiography % of neovascular membrane as measured by area of the neovascular lesion (in millimeters2). OCT angiography % regression of neovascular membrane as measured by area of the neovascular lesion (in millimeters2).


Secondary Outcome Measures :
  1. mean BCVA-ETDRS letter gain [ Time Frame: Week 24 and 52 ]

    Endpoints will be evaluated at 24 weeks and 52 weeks, unless indicated:

    Mean best corrected visual acuity (BCVA)

    • Proportion of patients with gain of ≥5, ≥10, or ≥15 ETDRS letters



Other Outcome Measures:
  1. OCTA neovascular membrane regression percentage (sub-study) [ Time Frame: week 1 through 12 ]

    In subjects participating in the sub-study of serial OCT Angiography during the initial 12 weeks)

    • OCT angiography % regression of neovascular membrane as measured by area of the neovascular lesion (in millimeters2) and vessel density (in millimeters-1) during the initial 12 weeks


  2. Mean Number of Injections [ Time Frame: week 24 and 52 ]
    Total number of injections received will be evaluated

  3. SD OCT Presence of SRF and SHRM [ Time Frame: week 24 and 52 ]
    • Presence of SD OCT intraretinal and subretinal fluid and subretinal hyper-reflective material (SHRM)

  4. Ocular AE [ Time Frame: Visit 1 through study completion ]
    • Incidence and severity of ocular adverse events

  5. Relevant Systemic SAE [ Time Frame: Visit 1 through study completion ]
    • Incidence and severity of relevant systemic serious adverse events

  6. OCTA neovascular membrane biomarker qualitative analysis (sub-study) [ Time Frame: Week 1-12 ]
    In subjects participating in the sub-study of serial OCT Angiography during the initial 12 weeks) OCT angiography qualitative analysis of morphological biomarkers of the neovascular complex including attenuation of the fringe during the initial 12 weeks

  7. SD OCT Analysis of Central Macular Thickness [ Time Frame: week 24 and 52 ]
    Change in SD OCT central macular thickness

  8. OCTA Analysis of vessel density [ Time Frame: Week 24 and 52 ]
    OCT angiography % of neovascular membrane as measured by area of the neovascular lesion (in millimeters2). OCT angiography % regression of neovascular membrane as measured by area of the neovascular lesion (in millimeters2).

  9. OCTA neovascular membrane biomarker qualitative analysis of flow-void areas(sub-study) [ Time Frame: Week 1-12 ]
    In subjects participating in the sub-study of serial OCT Angiography during the initial 12 weeks) OCT angiography qualitative analysis of morphological biomarkers of the neovascular complex including presence of flow-void areas during the initial 12 weeks

  10. OCTA neovascular membrane biomarker qualitative analysis of vessel looping (sub-study) [ Time Frame: Week 1-12 ]
    In subjects participating in the sub-study of serial OCT Angiography during the initial 12 weeks) OCT angiography qualitative analysis of morphological biomarkers of the neovascular complex including changes in vessel looping during the initial 12 weeks

  11. SD OCT Analysis of SRF Volume [ Time Frame: week 24 and 52 ]
    Change in volume of subretinal fluid

  12. SD OCT Analysis of SHRM Volume [ Time Frame: week 24 and 52 ]
    Change volume of SHRM

  13. SD OCT Analysis of CME [ Time Frame: week 24 and 52 ]
    Change in severity of cystoid macular edema

  14. SD OCT Analysis of PED Volume [ Time Frame: week 24 and 52 ]
    Change in volume of pigment epithelial detachment (PED)

  15. SD OCT Analysis of PED Height [ Time Frame: week 24 and 52 ]
    Change in height of PED



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject is older than 50 years of age.
  2. Subject is willing to participate in the study and able to follow the study criteria and protocol.
  3. The study eye is treatment naive regarding treatment of neovascular AMD.
  4. Subject is willing and able to comply with clinic visits and study-related procedures.
  5. Subject is able to provide signed informed consent.
  6. Subject is able to understand and complete study-related questionnaires.
  7. The subject is not currently involved with any other clinical study.
  8. Best Corrected Visual Acuity (BCVA) with ETDRS Snellen equivalent of 20/400 or better and 20/32 or worse.
  9. Sufficiently clear media (cornea, anterior chamber, lens, vitreous) for OCT, FA and fundus photography (FP).
  10. Intraocular pressure (IOP) of 25mmHg or less in the study eye, with or without use of ocular hypotensive agents.
  11. Prior focal corticosteroid treatment is allowed, as long as the study eye is not involved. However prior (within 90 days of Day 0) or current systemic corticosteroid therapy (oral or intravenous corticosteroid treatment) is not permitted.

Exclusion Criteria:

  1. Any prior treatment of neovascular AMD in the eye proposed for enrollment including previous anti-vascular endothelial factor (anti-VEGF) therapy, photodynamic therapy (PDT), radiation therapy, corticosteroid treatment, surgical treatment for CNV, thermal laser treatment, and any other prior intravitreal treatment for neovascular AMD (except minerals and vitamins).
  2. Known serious allergies to aflibercept, fluorescein dye, Indocyanine Green (ICG), shellfish, drugs for pupillary dilation, topical anesthetic, or sterilizing solution (e.g. Betadine Solution).
  3. Prior or current systemic anti-VEGF therapy.
  4. Pregnant or breast-feeding women.
  5. Sexually active men* or 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).
  6. Contraindication to pupillary dilation in study eye.
  7. Any condition (including inability to read visual acuity charts, or language barrier) that may preclude subjects ability to comply with the study protocol and requirements.
  8. Presence of any advanced systemic condition or end-stage disease, such as advanced Alzheimer Syndrome, end-stage cancer, etc., which will likely prevent subject from completing study.
  9. Previous therapeutic radiation in the region of the study eye.
  10. Prior retinal pigment epithelial (RPE) tear in study eye.
  11. Prior ocular surgery (except YAG laser capsulotomy) for study within the past 90 days.
  12. Anticipated ocular surgery (except YAG laser capsulotomy) for the next 12 months.
  13. Prior vitrectomy in the study eye.
  14. Presence of any causes of CNV and PED other than due to AMD or presence of ocular disease other than AMD affecting study eye, i.e. presumed ocular histoplasmosis syndrome, android streaks, pathologic myopia

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): NCT03022292


Locations
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United States, California
Stein Eye Institute of UCLA Recruiting
Los Angeles, California, United States, 90095
Contact: Sara A Yu, BA    310-825-7836    harmon@jsei.ucla.edu   
Contact: Lauren Downey, BS    310-794-5538    downey@jsei.ucla.edu   
Principal Investigator: David Sarraf, MD         
Sponsors and Collaborators
University of California, Los Angeles
Regeneron Pharmaceuticals

Publications:

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Responsible Party: David Sarraf, MD, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT03022292     History of Changes
Other Study ID Numbers: 16-000925
First Posted: January 16, 2017    Key Record Dates
Last Update Posted: December 24, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases