Ranibizumab Treatment for Macular Edema Secondary to Retinal Vein Occlusion

NCT04062370 | Unknown Phase 4

• 1 other identifier: 2019KYPJ092
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• best-corrected visual acuity (BCVA) at month 6

  best-corrected visual acuity (BCVA) at month 6

  Month 6 after first treatment

• 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

  Month 6 after first treatment

• the number of intravitreal injections of Ranibizumab at month 6

  the number of intravitreal injections of Ranibizumab at month 6

  Month 6 after first treatment

Secondary Outcomes (2)

• best-corrected visual acuity (BCVA) at month 12

  Month 12 after first treatment

• the number of intravitreal injections of Ranibizumab at month 12

  Month 12 after first treatment

Other Outcomes (9)

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

  during the follow-up for up to 12 months.

• intraocular pressure during the follow-up

  during the follow-up for up to 12 months.

• central macular thickness during the follow-up

  during the follow-up for up to 12 months.

Study Arms (2)

1+PRN

EXPERIMENTAL

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.

Drug: Ranibizumab; Device: laser photocoagulation

3+PRN

ACTIVE COMPARATOR

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.

Drug: Ranibizumab; Device: laser photocoagulation

Interventions

Ranibizumab DRUG

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.

Also known as: Lucentis

1+PRN; 3+PRN

laser photocoagulation DEVICE

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

1+PRN; 3+PRN

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Chuangxin Huang

Guangzhou, Guangdong, 510060, China

Location

Related Publications (1)

• Campochiaro PA, Hafiz G, Mir TA, Scott AW, Solomon S, Zimmer-Galler I, Sodhi A, Duh E, Ying H, Wenick A, Shah SM, Do DV, Nguyen QD, Kherani S, Sophie R. Scatter Photocoagulation Does Not Reduce Macular Edema or Treatment Burden in Patients with Retinal Vein Occlusion: The RELATE Trial. Ophthalmology. 2015 Jul;122(7):1426-37. doi: 10.1016/j.ophtha.2015.04.006. Epub 2015 May 9.

  PMID: 25972260 BACKGROUND

MeSH Terms

Conditions

Retinal Vein Occlusion

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Chenjin Jin, Ph.D

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanjie Yan

CONTACT

+8620-87332529; zocethics@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 29, 2019
• First Posted: August 20, 2019
• Study Start: October 1, 2019
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: August 20, 2019

Record last verified: 2019-08

Locations

CN (1)