Combination of Intravitreal Ranibizumab With or Without M... | NCT03690947

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

NCT03690947

Sponsor

Beijing Hospital

Status

Completed

Last Update Posted

Dec 28, 2022Actual

Enrollment

72Actual

Phase

Phase 4

Conditions

Diabetic Macular Edema

Interventions

Intravitreal Ranibizumab
Micropulse Laser
Intravitreal Ranibizumab as needed

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2018Actual

Primary Completion Date

Aug 31, 2021Actual

Completion Date

Sep 30, 2021Actual

First Submitted Date

Sep 28, 2018

First Submission Date that Met QC Criteria

Sep 28, 2018

First Posted Date

Oct 1, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 25, 2022

Last Update Posted Date

Dec 28, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

72Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Combination Therapy Group	Experimental		Drug: Intravitreal Ranibizumab Procedure: Micropulse Laser
Intravitreal Ranibizumab Group	Active Comparator		Drug: Intravitreal Ranibizumab Drug: Intravitreal Ranibizumab as needed

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intravitreal Ranibizumab	Drug	All subjections received 3 initial Ranibizumab injections	Combination Therapy Group Intravitreal Ranibizumab Group

Measure	Description	Time Frame
Best Corrected Visual Acuity changes	Compare the changes of BCVA between two groups	12 months

Measure	Description	Time Frame
Central Macular Thickness changes	Compare the changes of CMT between two groups	12 months

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Xiaobing Yu, M.D.	Beijing Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Hospital		Beijing	Beijing Municipality	100730	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36056443	Derived	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.

ID	Term
D000069579	Ranibizumab
D006301	Health Services Needs and Demand

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins