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Combination of Intravitreal Ranibizumab With or Without Micropulse Laser for the Treatment of DME

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03690947
Recruitment Status : Recruiting
First Posted : October 1, 2018
Last Update Posted : May 7, 2019
Sponsor:
Information provided by (Responsible Party):
Yu Xiaobing, Beijing Hospital

Brief Summary:
The objective of this study is to evaluate if combination of intravitreal ranibizumab with micropulse laser shows non inferiority compared to intravitreal ranibizumab only in diabetic macular edema.

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Drug: Intravitreal Ranibizumab Procedure: Micropulse Laser Drug: Intravitreal Ranibizumab as needed Phase 4

Detailed Description:

To investigate the efficacy of intravitreal ranibizumab injections compared to combination with Micropulse Laser in Chinese patients with visual impairment in DME.

The result of the study will be used to support new therapy in DME patients in China.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double-blinded, Controlled Clinical Trial of Combination of Intravitreal Ranibizumab With or Without Micropulse Laser for the Treatment of Diabetic Macular Edema
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
Drug Information available for: Ranibizumab

Arm Intervention/treatment
Experimental: Combination Therapy Group Drug: Intravitreal Ranibizumab
All subjections received 3 initial Ranibizumab injections
Other Name: Lucentis

Procedure: Micropulse Laser
After 3 initial Ranibizumab injections, Micropulse Laser will be done as needed each month if macular edema persists
Other Name: Macular Laser Photocoagulation

Active Comparator: Intravitreal Ranibizumab Group Drug: Intravitreal Ranibizumab
All subjections received 3 initial Ranibizumab injections
Other Name: Lucentis

Drug: Intravitreal Ranibizumab as needed
After 3 initial Ranibizumab injections, Ranibizumab will be injected as needed till BCVA reaches stabilization
Other Name: Lucentis




Primary Outcome Measures :
  1. Best Corrected Visual Acuity changes [ Time Frame: 12 months ]
    Compare the changes of BCVA between two groups


Secondary Outcome Measures :
  1. Central Macular Thickness changes [ Time Frame: 12 months ]
    Compare the changes of CMT between two groups



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Informed consent form must be signed before any tests or procedures are done
  • Male or female of 30 to 80 years of age (inclusive) at the first screening visit
  • Diagnosis of type 2 diabetes, with fasting blood glucose≤10mmol/L, HbA1C≤10.0%
  • Diabetic medication must be stable for at least 3 months before first screening visit and remain stable during study
  • Diagnosis of non-proliferative diabetic retinopathy with diabetic macular edema resulting in visual acuity reduction
  • Study eye's BCVA between 24 to 78 ETDRS letters at screening and baseline of the study
  • Macular edema of the study eye and central retinal thickness ≥300 µm determined by SD-OCT
  • Study eye had not had grid pattern photocoagulation, intraocular surgery, intravitreal corticosteroid injections and intravitreal anti-VEGF injections for at least 3 months before baseline
  • Non-study eye's BCVA ≥ 24 ETDRS letters at screening and baseline of the study
  • Non-study eye had not had intravitreal anti-VEGF injections for at least 3 months before baseline
  • If both eyes qualify, then investigators will choose an eye with worse BCVA as study eye. Only study eye will receive intravitreal ranibizumab and/or Micropulse Laser treatment

Exclusion Criteria:

  • Failure to follow study or follow-up procedures
  • Pregnant or breast-feeding woman and woman without adequate method of contraception
  • History of stroke or myocardial infarction within 3 months before screening
  • Renal failure or creatinine > 2.0 mg/dl
  • Uncontrolled systemic diseases or systemic treatment that may affect results of the study
  • Active ocular or intraocular infections of either eye
  • Neovascularization of the iris or neovascular glaucoma of either eye
  • A history of uveitis or vitreous macular traction in study eye
  • Glaucoma or IOP≥24 mmHg of study eye

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): NCT03690947


Contacts
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Contact: Xiaobing Yu, M.D. +86-010-85132171 yuxiaobing@sina.com

Locations
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China, Beijing
Beijing Hospital Recruiting
Beijing, Beijing, China, 100730
Contact: Xin Wang    +8613661174001    wangxinannie@126.com   
Sponsors and Collaborators
Beijing Hospital
Investigators
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Principal Investigator: Xiaobing Yu, M.D. Beijing Hospital
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Responsible Party: Yu Xiaobing, M.D., Beijing Hospital
ClinicalTrials.gov Identifier: NCT03690947    
Other Study ID Numbers: Z181100001718079
First Posted: October 1, 2018    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Email yuxiaobing@sina.com for individual participant data
Supporting Materials: Study Protocol

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Macular Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Ranibizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents