Intravitreal Bevacizumab vs Laser vs Combination of Bevacizumab and Modified Laser in PDR

NCT ID: NCT04800679

Last Updated: 2021-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-01

Study Completion Date

2021-12-31

Brief Summary

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In this randomized 3-armed clinical trial, 105 eyes with PDR will be included and divided randomly into 3 groups: IVB group (35 eyes) that receive 4 monthly IVB injections and then rescue IVB, PRP group (35 eyes) that undergo full PRP in 2 or 3 sessions and then rescue IVB, and combination group (35 eyes) that receive 2 bimonthly IVB injections and a modified laser (1 session anterior to the equator) and then rescue IVB or laser. Diabetic macular edema (DME) will be treated independently in all groups by IVB. Primary outcome will be the number and activity of neovascularizations at 4,8 and 12 months and secondary measures will be changes in best corrected visual acuity (BCVA) and central macular thickness (CMT), and number of examinations and injection.

Detailed Description

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Conditions

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Proliferative Diabetic Retinopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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intravitreal bevacizumab injections and then rescue

Group Type ACTIVE_COMPARATOR

receive 4 monthly IVB injections and then rescue IVB

Intervention Type DRUG

IVB group that receive 4 monthly IVB injections and then rescue IVB

PRP group

Group Type ACTIVE_COMPARATOR

PRP group

Intervention Type DRUG

PRP group that undergo full PRP in 2 or 3 sessions and then rescue IVB

IVB injections and a modified laser

Group Type ACTIVE_COMPARATOR

IVB injections and a modified laser

Intervention Type DRUG

Combination group that receive 2 bimonthly IVB injections and a modified laser (1 session anterior to the equator) and then rescue IVB or laser

Interventions

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receive 4 monthly IVB injections and then rescue IVB

IVB group that receive 4 monthly IVB injections and then rescue IVB

Intervention Type DRUG

PRP group

PRP group that undergo full PRP in 2 or 3 sessions and then rescue IVB

Intervention Type DRUG

IVB injections and a modified laser

Combination group that receive 2 bimonthly IVB injections and a modified laser (1 session anterior to the equator) and then rescue IVB or laser

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Presence of PDR with the indication of full PRP according the intend of investigator
* Best corrected visual acuity of 20/320 or better
* Media clarity, pupillary dilation and patient's cooperation sufficient for full PRP, wide-field FAG and OCT

Exclusion Criteria

* History of prior PRP with more than 100 burns outside the posterior pole
* Tractional retinal detachment involving the macula
* Evidence of neoplasia of angle on examination
* Macular edema due to a cause other than DME
* Any ocular condition which may change visual acuity during the study
* Substantial cataract which has declined the vision by 3 lines or more
* History of intravitreal injection of anti-VEGF agent in past 2 months
* History of any use of corticosteroid during past 4 months
* History of major intra-ocular surgery except cataract surgery
* History of YAG laser capsulotomy during past 2 months
* Aphakia and uncontrolled glaucoma according to investigator judgment
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Zahra Rabbani Khah

Head of ophthalmic research center

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ophthalmic Research Center

Tehran, , Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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Alireza Ramezani, MD

Role: CONTACT

009822591616

Facility Contacts

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Ali reza Ramezani, MD

Role: primary

009822591616

References

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Shahraki T, Arabi A, Nourinia R, Beheshtizadeh NF, Entezari M, Nikkhah H, Karimi S, Ramezani A. PANRETINAL PHOTOCOAGULATION VERSUS INTRAVITREAL BEVACIZUMAB VERSUS A PROPOSED MODIFIED COMBINATION THERAPY FOR TREATMENT OF PROLIFERATIVE DIABETIC RETINOPATHY: A Randomized Three-Arm Clinical Trial (CTPDR Study). Retina. 2022 Jun 1;42(6):1065-1076. doi: 10.1097/IAE.0000000000003450.

Reference Type DERIVED
PMID: 35594075 (View on PubMed)

Other Identifiers

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97378

Identifier Type: -

Identifier Source: org_study_id

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