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Comparative Multicenter Randomized Study of Aflibercept Versus Placebo in Macular Telangiectasia Type 1 (TELeMAC)

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ClinicalTrials.gov Identifier: NCT03845049
Recruitment Status : Not yet recruiting
First Posted : February 19, 2019
Last Update Posted : February 19, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

Tracking Information
First Submitted Date  ICMJE February 15, 2019
First Posted Date  ICMJE February 19, 2019
Last Update Posted Date February 19, 2019
Estimated Study Start Date  ICMJE March 2019
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 15, 2019)
Change in central retinal thickness (CRT) [ Time Frame: Between M0 and M6 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparative Multicenter Randomized Study of Aflibercept Versus Placebo in Macular Telangiectasia Type 1
Official Title  ICMJE Comparative Multicenter Randomized Study of Aflibercept Versus Placebo in Macular Telangiectasia Type 1
Brief Summary Idiopathic juxtafoveal telangiectasia type 1 is a rare unilateral disease that mostly affects men before 50 years of age. Mac Tel 1 are characterized by microvascular telangiectasia and increased tortuosity of the macular capillary network on the temporal part of the fovea that can be identified on fundus examination. It can be associated with peripheral vascular changes, similar to manifestations of Coats' disease. It can be complicated by macular edema due to leakage from microvascular ectasia. When associated with visual loss, macular edema can be treated with different strategies although there is no consensus about the best approach. Laser can be performed on leaky aneurysms with questionable long term efficacy and potential irreversible adverse effects. Recently, anti-VEGF agents have been put forward as particularly good candidates to treat this macular edema, as observed in vein occlusion or diabetic macular edema. Indeed, in limited case series, the first anti-VEGF agents (ranibizumab and bevacizumab) showed mitigated results. More recently, authors have reported some favorable results with aflibercept in patients refractory to other anti-VEGF agents. Indeed a recent study reported both good anatomical and functional results in macular edema due to Mac Tel 1 in a non-comparative study that included 8 patients and carried out a concomitant quantification of growth factors. As an explanation, the authors found that levels of placental growth factor (PlGF), which is targeted by aflibercept but not by other anti-VEGF agents, were decreased after treatment. Moreover, PlGF correlated with capillary plexus densities assessed by OCTA. The aim of this study is thus to assess the efficacy of a 6 months treatment by aflibercept compared to placebo in macular edema linked to Mac Tel 1 with a multicenter double-blind randomized clinical trial.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Patient With Idiopathic Macular Telangiectasia Type 1 Identified
Intervention  ICMJE
  • Other: Inclusion examinations
    Pregnancy test, Visual acuity, ocular pressure, color retinophotography, OCT-SD (the Heidelberg SDOCT Spectralis, or the Cirrus HD-OCT, model 5000, Zeiss), OCT-angiography and fluorescein angiography and wide-field angiogram
  • Drug: Aflibercept Injection [Eylea]
    Intravitreal injection of aflibercept at inclusion, M1, M2, M3 and M4. An additional injection may be planned for M5, on the decision of the clinician and on clinical arguments only.
  • Drug: SHAM injection
    Intravitreal injection of SHAM at inclusion, M1, M2, M3 and M4. An additional injection may be planned for M5, on the decision of the clinician and on clinical arguments only.
  • Other: Examinations during study (every month)
    visual acuity, ocular pressure, OCT-SD, OCT-angiography and ocular fundus and a pregnancy test at M6
Study Arms  ICMJE
  • Experimental: group aflibercept
    Interventions:
    • Other: Inclusion examinations
    • Drug: Aflibercept Injection [Eylea]
    • Other: Examinations during study (every month)
  • Placebo Comparator: control group
    Interventions:
    • Other: Inclusion examinations
    • Drug: SHAM injection
    • Other: Examinations during study (every month)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: February 15, 2019)
46
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient who have given their written informed consent
  • Patient aged between 18 and 65 years inclusive
  • Patient with idiopathic macular telangiectasia type 1 identified at least 6 months previously, with or without peripheral exudative abnormalities
  • Patient with macular edema more than 320 μm confirmed by a blind review of SD-OCT images
  • Patient with best-corrected ETDRS visual acuity between >24 and < 79 letters
  • Patient with a contraindication for laser photocoagulation or with persistence of macular edema after treatment with intravitreal bevacizumab, ranibizumab and/or laser photocoagulation administered more than 6 months previously
  • Patient with an assessment by the treating ophthalmologist that focal coagulation (for both groups) and anti-VEGF treatment (for the placebo group) could be safely deferred for 6 months
  • Woman of childbearing potential (WOCBP)* must commit to consider and use an efficient method of birth control during the trial and at least 3 months after the last aflibercept/SHAM administration

Exclusion Criteria:

  • Patient not affiliated to a national health insurance scheme
  • Patient subject to a measure of legal protection (guardianship, tutorship)
  • Patient subject to a court order
  • Patient pregnant, parturient or nursing women (WOCBP)*
  • Patient incapable of expressing consent
  • Patient with edema linked to conditions other than macular telangiectasia (namely retinal vein occlusion, diabetic retinopathy, ocular ischemic syndrome, sickle-cell anemia, maculopathy, hypertensive retinopathy…)
  • Patient treated with aflibercept before inclusion
  • Patient presenting any cardiovascular eventwithin 6 months before inclusion
  • Poor media clarity, which can prevent adequate fundus imaging
  • Patient having prior focal photocoagulation within the previous 4 months
  • Patient with hypersensitivity to the active substance (aflibercept) or to any of the excipients of EYLEA®
  • Patient with active or suspected ocular or periocular infection or severe active intraocular inflammation.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Catherine CREUZOT GARCHER +33 3 80 29 51 73 catherine.creuzot-garcher@chu-dijon.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03845049
Other Study ID Numbers  ICMJE CREUZOT PHRC N 2017
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centre Hospitalier Universitaire Dijon
Study Sponsor  ICMJE Centre Hospitalier Universitaire Dijon
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Centre Hospitalier Universitaire Dijon
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP