NCT04063358

Brief Summary

The investigators aim to evaluate how different timing of anti-VEGF intravitreous injections affect visual acuity (BCVA) in patients with diabetic macular edema who are undergoing cataract surgery; and to evaluate how different timing of anti-VEGF intravitreous affect OCT CSF thickness and total number of postoperative injections in patients with diabetic macular edema who are undergoing cataract surgery.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 21, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

August 22, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
Last Updated

March 26, 2020

Status Verified

March 1, 2020

Enrollment Period

2 years

First QC Date

August 19, 2019

Last Update Submit

March 25, 2020

Conditions

Diabetic Macular EdemaCataract

Outcome Measures

Primary Outcomes (2)

  • Change in best-corrected visual acuity (BCVA)

    BCVA is a measurement of the best vision correction that can be achieved, such as glasses, as measured on the standard Snellen eye chart. For example, if uncorrected eyesight is 20/200, but patient can see 20/20 with glasses, the BCVA is 20/20.

    1 month, 3 months , 6 months and 12 months after cataract surgery

  • Change in optical coherence tomography (OCT) central subfield (CSF) thickness

    Optical coherence tomography (OCT) is an important imaging modality in the evaluation and management of retinal diseases. Change in central subfield (CSF) thickness will be measured and recorded.

    24 hours post-operatively, 1 month, 3 months , 6 months and 12 months after cataract surgery

Secondary Outcomes (2)

  • Total number of postoperative injections

    12 months after cataract surgery

  • percentage of patients with diabetic retinopathy progression

    12 months after cataract surgery

Study Arms (3)

Lucentis injected Pre-operatively

EXPERIMENTAL

Lucentis injected 2 weeks before cataract surgery

Drug: Lucentis

Lucentis injected intra-operatively

ACTIVE COMPARATOR

Lucentis injected during the course of the surgery by cataract surgeon.

Drug: Lucentis

Lucentis injected post-operatively

EXPERIMENTAL

Lucentis injected 2 weeks after cataract surgery

Drug: Lucentis

Interventions

LucentisDRUG

Lucentis 0.5 MG Per 0.05 ML Injection

Lucentis injected Pre-operativelyLucentis injected intra-operativelyLucentis injected post-operatively

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults over age 18 with diabetes mellitus, diabetic macular edema and visually significant cataracts planning to undergo cataract surgery

You may not qualify if:

  • Patients who have undergone panretinal photocoagulation (PRP) in prior 4 months or an ocular condition (other than cataract and DME) that might affect visual acuity during course of study.
  • Patients with history of vitrectomy. Patients with neovascular glaucoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, 86-21, China

RECRUITING

MeSH Terms

Conditions

Cataract

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • wei shen

    Changhai Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

dongyan pan

CONTACT

86-21-31161995campus@126.com

wei shen

CONTACT

86-21-31161995shenwzz@163.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 19, 2019

First Posted

August 21, 2019

Study Start

August 22, 2019

Primary Completion

August 31, 2021

Study Completion

August 31, 2021

Last Updated

March 26, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)