Back to results

Ranibizumab Treatment for Macular Edema Secondary to Retinal Vein Occlusion

Primary Purpose

Retinal Vein Occlusion, Treatment, Photocoagulation Burn to Retina

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Ranibizumab

laser photocoagulation

About this trial

This is an interventional treatment trial for Retinal Vein Occlusion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with RVO-ME diagnosed definitely by FFA and OCT, with CMT > 300μm; BCVA from 20/200 to 20/40 (including 20/200 and 20/40), with a degree of myopia ≤-6 diopter (diopter, D);
Patients with a course of RVO ≤ 12 weeks; Patients who have not received laser, intraocular or systemic anti-VEGF treatments or long-acting hormone intraocular, periocular or systemic treatments since the onset of RVO;
Patients who are voluntary to sign and date the informed consent form approved by the Ethics Review Committee prior to the conduct of the relevant study steps.

Exclusion Criteria:

Patients with a course of disease > 12 weeks;
Patients treated with any anti-angiogenic medicines for either eye within 3 months before the baseline; or patients currently in treatment with systemic anti-angiogenic drugs;
Patients with their study eyes treated with panretinal photocoagulation (PRP) previously;
Patients previously participating in other clinical trials 3 months before the baseline;
Patients with severely opacity of refractive media affecting laser treatment and observation;
Patients with other ophthalmic diseases affecting visual prognosis, such as corneal disease, glaucoma, severe cataract, uveitis, other fundus diseases, etc.
Patients with in any condition where intravitreal injection is unacceptable;
Patients identified by the investigator to be medically or mentally unstable: complicated with cardiovascular, cerebrovascular, liver, kidney and hematopoietic system and other serious primary diseases or mental disease; Women who are pregnant or preparing for pregnancy or in lactation, etc.
Patients with any history may interfere with the results of the trial or increase the risk of the patient (assessed by the investigator) ;
Patients who are in poor compliance and unable to strictly implement the protocol (assessed by the investigator).

Sites / Locations

Chuangxin Huang

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1+PRN

3+PRN

Arm Description

Intravitreal injection of Ranibizumab 0.5 mg (IVR): initial injection for 1 time ( month 1), and then IVR is required if central macular thickness (CMT) greater than 300 μm during the follow-up observation (Pro re nata, PRN, means if necessary). After 6 months follow-up, patients in this arm will be randomly divided to receive IVR PRN only or laser photocoagulation combined with IVR PRN. IVR PRN only: patient will receive IVR PRN if CMT greater than 300 μm during the follow-up observation (PRN) after month 6. Laser photocoagulation with IVR PRN: patient will receive laser photocoagulation for non-perfusion area according to FFA results after month 6, and then received IVR PRN if CMT greater than 300 μm.

Intravitreal injection of Ranibizumab 0.5 mg (IVR): initial injection for 3 consecutive times ( months 1, 2 and 3 ),and then IVR is required if CMT greater than 300 μm during the follow-up observation (PRN). After 6 months follow-up, patients in this arm will be randomly divided to receive IVR PRN only or laser photocoagulation combined with IVR PRN. IVR PRN only: patient will receive IVR PRN if CMT greater than 300 μm during the follow-up observation (PRN) after month 6. Laser photocoagulation with IVR PRN: patient will receive laser photocoagulation for non-perfusion area according to FFA results after month 6, and then received IVR PRN if CMT greater than 300 μm.

Outcomes

Primary Outcome Measures

best-corrected visual acuity (BCVA) at month 6

Central macular thickness (CMT) at month 6 (3) the number of intravitreal injections of Ranibizumab at month 6

Central macular thickness (CMT) at month 6

the number of intravitreal injections of Ranibizumab at month 6

Secondary Outcome Measures

best-corrected visual acuity (BCVA) at month 12

the number of intravitreal injections of Ranibizumab at month 12

Full Information

NCT ID

NCT04062370

First Posted

July 29, 2019

Last Updated

August 18, 2019

Sponsor

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT04062370

Brief Title

Ranibizumab Treatment for Macular Edema Secondary to Retinal Vein Occlusion

Official Title

Different Regimens of Ranibizumab Treatment for Macular Edema Secondary to Retinal Vein Occlusion: a Randomized and Controlled Clinical Study.

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Unknown status

Study Start Date

October 1, 2019 (Anticipated)

Primary Completion Date

August 31, 2022 (Anticipated)

Study Completion Date

August 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Retinal vein occlusion (RVO) may lead to series of complications including retinal ischemia, macular edema (ME) and induce vision impairment. Intravitreal injection of Ranibizumab (0.5mg) has been proved to be a safe and effective method for the treatment of RVO-ME. In this study, different treatment regimens of Ranibizumab is applied and the effects is observed at 1-6 months to explore the best regimen for RVO. After 6 months, anti-VEGF therapy and/or laser photocoagulation is used to explore whether laser photocoagulation can maintain the therapeutic effect of Ranibizumab or reduce the injection number.

Detailed Description

Retinal vein occlusion (RVO) may lead to series of complications including retinal ischemia, macular edema (ME) and so on. Retinal vein occlusion (RVO) can be classified as branch retinal vein occlusion (BRVO) and central retinal vein occlusion (CRVO). Retinal vein occlusion with macular edema (RVO-ME) is the main cause of RVO induced vision impairment. Intravitreal injection of Ranibizumab (0.5mg) has been proved to be a safe and effective method for the treatment of RVO-ME. Although multiple injections of anti-vascular endothelial growth factor (anti-VEGF) drugs are beneficial to the therapeutic results of RVO-ME, they may also increase the risk of systemic or ocular complications and at the same time increase the economic burden of patients to a certain extent. Different studies have shown that anti-VEGF therapy with low frequency injection (2-5 doses) is also effective for RVO-related ME. However, there are still different views on which option is better. Meanwhile, the effect of laser photocoagulation in the non-perfusion area of the retina, and whether the number of subsequent anti-VEGF injections can be reduced accordingly, is still uncertain. Therefore, in this study, different treatment regimens will be applied and the effects will be observed at 1-6 months. After 6 months, anti-VEGF therapy and/or laser photocoagulation will be used to explore whether laser photocoagulation can maintain the therapeutic effect or reduce the injection number of Ranibizumab. This study intends to explore the therapeutic effects of different treatment regimens on RVO-ME, and meanwhile to investigate the dynamic changes in retinal morphology, microcirculation and visual function during RVO treatment by means of angiography-optical coherence tomography (angio-OCT), microperimetry, electroretinogram (ERG) examination and other methods.

6. Conditions and Keywords

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

Retinal Vein Occlusion, Treatment, Photocoagulation Burn to Retina, Ranibizumab

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

This is a prospective, randomized, controlled, parallel, open-label, exploratory clinical trial. Including 100 patients, 50 : 50 in each arm. Different frequency of Ranibizumab is applied in this study.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

1+PRN

Arm Type

Experimental

Arm Description

Arm Title

3+PRN

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Ranibizumab

Other Intervention Name(s)

Lucentis

Intervention Description

Patients will receive intravitreal injection of Ranibizumab 0.5 mg (1+PRN or 3+PRN) according to the study until month 6. Then, patients will received Ranibizumab PRN only or laser photocoagulation with Ranibizumab PRN after month 6.

Intervention Type

Device

Intervention Name(s)

laser photocoagulation

Intervention Description

After month 6, patients will received Ranibizumab PRN only or laser photocoagulation with Ranibizumab PRN according the re-randomization at month 6.

Primary Outcome Measure Information:

Title

best-corrected visual acuity (BCVA) at month 6

Description

best-corrected visual acuity (BCVA) at month 6

Time Frame

Month 6 after first treatment

Title

Central macular thickness (CMT) at month 6 (3) the number of intravitreal injections of Ranibizumab at month 6

Description

Central macular thickness (CMT) at month 6

Time Frame

Month 6 after first treatment

Title

the number of intravitreal injections of Ranibizumab at month 6

Description

the number of intravitreal injections of Ranibizumab at month 6

Time Frame

Month 6 after first treatment

Secondary Outcome Measure Information:

Title

best-corrected visual acuity (BCVA) at month 12

Description

best-corrected visual acuity (BCVA) at month 12

Time Frame

Month 12 after first treatment

Title

the number of intravitreal injections of Ranibizumab at month 12

Description

the number of intravitreal injections of Ranibizumab at month 12

Time Frame

Month 12 after first treatment

Other Pre-specified Outcome Measures:

Title

best-corrected visual acuity (BCVA) during the follow-up

Description

best-corrected visual acuity (BCVA) during the follow-up

Time Frame