Clincosm LogoSign in Get a demo

UWFA-RVO-ME: Ultra-wide-field Fluorescein Angiography in Patients With Macular Edema Secondary to Retinal Vein Occlusion

Sponsor
Renmin Hospital of Wuhan University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04140448
Collaborator
(none)
60
Enrollment
1
Location
25.5
Anticipated Duration (Months)
2.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study mainly observed the ischemic index and vascular leakage index changes on ultra-wide field fluorescence angiography after anti-VEGF treatment , and whether these changes correlated with treatment efficacy in patients with macular edema secondary to retinal vein occlusion.

Condition or Disease Intervention/Treatment Phase
  • Drug: Ranibizumab 0.5 MG/0.05 ML Intraocular Solution [LUCENTIS]
  • Device: Ultra-wide Fluorescein Angiography

Detailed Description

Ultra-wide field fluorescence angiography can clearly observe the peripheral retina. This study mainly observes the ischemic index and vascular leakage index changes on UWFA after anti-VEGF treatment and evaluates these changes associated with treatment efficacy in patients with macular edema secondary to retinal vein occlusion.

Study Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Ultra-wide-field Fluorescein Angiography in Patients With Macular Edema Secondary to Retinal Vein Occlusion
Anticipated Study Start Date :
Nov 1, 2019
Anticipated Primary Completion Date :
Oct 30, 2021
Anticipated Study Completion Date :
Dec 15, 2021

Arms and Interventions

Arm Intervention/Treatment
UWFA-RVO-ME

Ultra-wide-field fundus fluorescein angiography on patients with macular edema secondary to retinal vein occlusion treated with Ranibizumab

Drug: Ranibizumab 0.5 MG/0.05 ML Intraocular Solution [LUCENTIS]
Intravitreal injection of Ranibizumab 0.5 MG/0.05 ML
Other Names:
  • Lucentis
  • Anti-VEGF

    • Device: Ultra-wide Fluorescein Angiography
    Ultra-wide-field Fluorescein Angiography can clearly observe the peripheral retina

    Outcome Measures

    Primary Outcome Measures

    1. Change in vascular leakage index in different retinal area [Baseline and 1,2,3,4,6,9 and 12 months]

      Change in vascular leakage index in different retinal area from baseline to 1,2,3,4,6,9 and 12 months

    2. Change in non-perfused areas in different retinal area [Baseline and 1,2,3,4,6,9 and 12 months]

      Change in non-perfused areas in different retinal area from baseline to 1,2,3,4,6,9 and 12 months

    Secondary Outcome Measures

    1. Change in best corrected visual acuity [Baseline and 1,2,3,4,6,9 and 12 months]

      Change in best corrected visual acuity from baseline to 1,2,3,4,6,9 and 12 months

    2. Change in central macular thickness [Baseline and 1,2,3,4,6,9 and 12 months]

      Change in central macular thickness from baseline to1,2,3,4,6,9 and12 months

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Male or female aged 18 years or older

    2. Macular edema secondary to CRVO,BRVO or HRVO

    3. Duration of RVO not more than 4 months

    4. Naïve patients. Patient with previous RVO (more than 12 months before the inclusion date) completely resolved (normalization of visual acuity and fundus examination) and who have experienced a recurrence of RVO are also considered naive

    5. Patient who agrees to participate in the study and who has given his/her written, informed consent

    Exclusion Criteria:

    1. Patient with another retinal disease in the study eye: diabetic retinopathy, maculopathy of any cause (age-related macular degeneration, epimacular membrane, myopia, etc) responsible for decreased vision, advanced glaucoma, cataract severely affecting vision and/or requiring surgical treatment during the 24 months study period

    2. Active or suspected ocular or periocular infection

    3. Active severe intraocular inflammation

    4. RVO complicated with neovascularization

    5. Patient who has previously undergone laser panretinal photocoagulation, grid-laser or photodynamic therapy, any anti-VEGF or corticoids intravitreal injections in the study eye

    6. Patient already included in the study for the treatment of the fellow eye

    7. Pregnant or breastfeeding woman

    8. Lack of effective contraception for women of childbearing age

    9. Patient taking part in an interventional study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Renmin Hospital of Wuhan University Wuhan Hubei China 430060

    Sponsors and Collaborators

    • Renmin Hospital of Wuhan University

    Investigators

    • Principal Investigator: CZ Chen, PHD, Renmin Hospital of Wuhan University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Changzheng Chen, Chief of Department of Ophthalmology, Renmin Hospital of Wuhan University
    ClinicalTrials.gov Identifier:
    NCT04140448
    Other Study ID Numbers:
    • UWFA-RVO-ME
    First Posted:
    Oct 25, 2019
    Last Update Posted:
    Oct 30, 2019
    Last Verified:
    Oct 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Changzheng Chen, Chief of Department of Ophthalmology, Renmin Hospital of Wuhan University
    Ultra-wide field fundus fluorescein angiography
    ischemic index
    vascular leakage index
    Additional relevant MeSH terms:
    Macular Edema
    Retinal Vein Occlusion
    Edema
    Ranibizumab

    Study Results

    No Results Posted as of Oct 30, 2019