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Effects of Ranibizumab to Delay or Regression Non-proliferative Diabetic Retinopathy(NPDR) With DME Assessed by Microaneurysm Changes: A Pilot Study

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ClinicalTrials.gov Identifier: NCT02834663
Recruitment Status : Unknown
Verified July 2016 by Wonkwang University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : July 15, 2016
Last Update Posted : July 15, 2016
Sponsor:
Collaborator:
Novartis Korea Ltd.
Information provided by (Responsible Party):
Wonkwang University Hospital

Brief Summary:

Title of study:

Effects of Ranibizumab to delay or regression non-proliferative diabetic retinopathy(NPDR) with DME assessed by microaneurysm changes: A pilot study Objectives To evaluate the effects of intravitreal Ranibizumab injection on microvascular changes in eyes of mild-to-moderate NPDR with DME

Primary objective:

To compare microvascular changes assessed by microaneurysm counts in eyes of mild-to-moderate NPDR with DME after intravitreal Ranibizumab injection from baseline through 6 months after treatment.

Secondary objectives:

To investigate other efficacy endpoints including other microvascular, anatomical, visual acuity change and safety in mild-to-moderate NPDR with DME after intravitreal Ranibizumab injection from baseline through 6 months after treatment.


Condition or disease Intervention/treatment Phase
Age-related Macular Degeneration Drug: Lucentis Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Effects of Ranibizumab to Delay or Regression Non-proliferative Diabetic Retinopathy(NPDR) With DME Assessed by Microaneurysm Changes: A Pilot Study
Study Start Date : July 2016
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab

Arm Intervention/treatment
Experimental: Lucentis Drug: Lucentis



Primary Outcome Measures :
  1. icroaneurysm counts in FAG (mm²) on 1,2 and 3 fields on ETDRS(by Fundus Photograph)) [ Time Frame: 6 months ]
    using Retmarker DR software

  2. Microaneurysm turnover rate in FAG (mm²) [ Time Frame: 6 months ]
    microaneurysm formation rate index = (number of new microaneurysms detected at 6 months follow Up/number of microaneurysms at baseline) * 100


Secondary Outcome Measures :
  1. Non-perfusion area in FAG (mm²) in periphery [ Time Frame: 6 months ]
    1,2 and 3 fields on ETDRS(by Fundus Photograph)

  2. Cotton wool spot & hard exudation count in fundus photo & OCT (mm²) [ Time Frame: 6 months ]
  3. changes in CMT(central macular thickness) [ Time Frame: 6 months ]
    1 mm ETDRS by spectralis OCT ; Heidelberg Engineering

  4. The changes in best corrected visual acuity (BCVA) [ Time Frame: 6 months ]
    using ETDRS chart

  5. Safety parameters [ Time Frame: 6 months ]
    Systemic adverse events (MI, CVA, etc), Ocular adverse events (retinal detachment, RPE tear, endophthalmitis, uveitis, vitreous hemorrhage, subretinal hemorrhage, cataract , IOP elevation, etc)



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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:

  • Patients (Male & female) ≥18 years of age
  • Type 1 or 2 DM (HbA1c 7.5%)
  • Best corrected visual acuity 30/20 to 20/200 (Snellen equivalent using ETDRS chart)
  • Mild to moderate NPDR with DME Classification of diabetic retinopathy in the ETDRS

    • Mild NPDR - At least one microaneurysm, AND criteria not met for more severe retinopathy
    • Moderate NPDR - Hemorrhage/microaneury ≥ standard photograph 2A ; and/or cotton wool spots, venous beading, or IRMA definitely present; and criteria not met for more severe retinopathy
    • Severe NPDR - Cotton wool spots, venous beading, and IRMA definitely present in at least two of photographic fields 4 to 7 ; or two of the three preceding features present in at least two of fields 4 to 7 and hemorrhages/microaneurysm present in fields 4 to 7≥ standard photograph 2A in at least one of them ; or IRMA present in each of fields 4 to 7 and ≥ standard photography 8A in at least two of them ; and criteria not met for more severe retinopathy

Exclusion Criteria:

  • PDR - NVE & NVD
  • Early PDR - New vessels ; and criteria not met for high-risk PDR
  • High risk PDR - New vessels on or within one disc diameter of the optic disc (neovascularization of the disc) ≥ standard photograph 10A with or without vitreous or preretinal hemorrhage ; or vitreous and/or preretinal hemorrhage accompanied by new vessels, either NVD ≤ standard photograph 10A or new vessels elsewhere (NVE) ≥ 1/4 disc area
  • Vitreous hemorrhage
  • Prior intraocular operation history.
  • Pars Plana Vitrectomy, RD surgery, recent (4 months) cataract Op, et al
  • Prior any intravitreal injection history.
  • Lucentis, Eylea, Macugen, Avastin, Triamcinolone et al
  • Prior pan retinal photocoagulation(PRP) or sector scatter photocoagulation was done.
  • Uncontrolled hypertension.
  • Uncontrolled glaucoma.

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): NCT02834663


Contacts
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Contact: Yunsik Yang, MD, Ph D +8201026890452 yunsikyang@naver.com

Sponsors and Collaborators
Wonkwang University Hospital
Novartis Korea Ltd.

Publications:

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Responsible Party: Wonkwang University Hospital
ClinicalTrials.gov Identifier: NCT02834663     History of Changes
Other Study ID Numbers: CRFB002DKR03T
First Posted: July 15, 2016    Key Record Dates
Last Update Posted: July 15, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Macular Degeneration
Diabetic Retinopathy
Microaneurysm
Retinal Degeneration
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Aneurysm
Ranibizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents