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

Primary Purpose

Diabetic Macular Edema

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Intravitreal Ranibizumab

Micropulse Laser

Intravitreal Ranibizumab as needed

About this trial

This is an interventional treatment trial for Diabetic Macular Edema

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Beijing Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Combination Therapy Group

Intravitreal Ranibizumab Group

Arm Description

Outcomes

Primary Outcome Measures

Best Corrected Visual Acuity changes

Compare the changes of BCVA between two groups

Secondary Outcome Measures

Central Macular Thickness changes

Compare the changes of CMT between two groups

Full Information

NCT ID

NCT03690947

First Posted

September 28, 2018

Last Updated

December 25, 2022

Sponsor

Beijing Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03690947

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Completed

Study Start Date

October 1, 2018 (Actual)

Primary Completion Date

August 31, 2021 (Actual)

Study Completion Date

September 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Beijing Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Macular Edema

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

72 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Combination Therapy Group

Arm Type

Experimental

Arm Title

Intravitreal Ranibizumab Group

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Intravitreal Ranibizumab

Other Intervention Name(s)

Lucentis

Intervention Description

All subjections received 3 initial Ranibizumab injections

Intervention Type

Procedure

Intervention Name(s)

Micropulse Laser

Other Intervention Name(s)

Macular Laser Photocoagulation

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Intravitreal Ranibizumab as needed

Other Intervention Name(s)

Lucentis

Intervention Description

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

Primary Outcome Measure Information:

Title

Best Corrected Visual Acuity changes

Description

Compare the changes of BCVA between two groups

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Central Macular Thickness changes

Description

Compare the changes of CMT between two groups

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xiaobing Yu, M.D.

Organizational Affiliation

Beijing Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Beijing Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100730

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Email yuxiaobing@sina.com for individual participant data

Citations:

PubMed Identifier

36056443

Citation

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.

Results Reference

derived

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

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