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CompletedNCT03690947Updated Dec 28, 2022

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

A Phase 4 interventional study of Intravitreal Ranibizumab and Micropulse Laser in Diabetic Macular Edema, sponsored by Beijing Hospital. Completed at 1 site in China. Open to participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-12-28.

Sponsored by Beijing Hospital · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
30 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Diabetic Macular Edema

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03

In context

Macular Edema

841 studies on the registry are indexed under Macular Edema; 56 are open to participants now.

This study's enrollment of 72 is above the median of 50 across 619 interventional studies indexed under Macular Edema.

Browse Macular Edema studies →

Lead sponsor

Beijing Hospital is the lead sponsor of 51 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
72 participants (actual)

Study arms

  • Experimental
    Combination Therapy Group

    Drug: Intravitreal Ranibizumab · Procedure: Micropulse Laser

  • Active comparator
    Intravitreal Ranibizumab Group

    Drug: Intravitreal Ranibizumab · Drug: Intravitreal Ranibizumab as needed

Interventions

  • DrugIntravitreal Ranibizumab

    All subjections received 3 initial Ranibizumab injections

    Also known as: Lucentis

  • ProcedureMicropulse Laser

    After 3 initial Ranibizumab injections, Micropulse Laser will be done as needed each month if macular edema persists

    Also known as: Macular Laser Photocoagulation

  • DrugIntravitreal Ranibizumab as needed

    After 3 initial Ranibizumab injections, Ranibizumab will be injected as needed till BCVA reaches stabilization

    Also known as: Lucentis

06

What researchers measure

Primary outcomes

  1. Best Corrected Visual Acuity changes

    Compare the changes of BCVA between two groups

    Time frame: 12 months

Secondary outcomes

  1. Central Macular Thickness changes

    Compare the changes of CMT between two groups

    Time frame: 12 months

07

Study locations

1 site
  • Beijing Hospital
    Beijing, Beijing 100730, China
08

References and documents

Publications

  • Mi X, Gu X, Yu X. The efficacy of micropulse laser combined with ranibizumab in diabetic macular edema treatment: study protocol for a randomized controlled trial. Trials. 2022 Sep 2;23(1):736. doi: 10.1186/s13063-022-06593-2. PubMed 36056443 ↗

Individual participant data

Plan to share: Yes — Email yuxiaobing@sina.com for individual participant data

Supporting information: Study protocol

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 28, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03690947
Lead sponsor
Beijing Hospital
Responsible party
Yu Xiaobing (M.D., Beijing Hospital) — Principal investigator
First posted
Oct 1, 2018
Start date
Oct 1, 2018
Primary completion
Aug 31, 2021
Completion
Sep 30, 2021
Last update
Dec 28, 2022

Study contacts

Xiaobing Yu, M.D.
principal investigator · Beijing Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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