Injection of Ranibizumab Versus Combination of Ranibizumab and Triamcinolone Acetate for (CRVO)

NCT04460001 | Unknown Phase 2

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

Brief Summary

To compare the clinical effectiveness of ranibizumab and combination of ranibizumab and triamcinolone for the treatment of macular oedema secondary to CRVO

Conditions

Ophthalmopathy

Outcome Measures

Primary Outcomes (2)

• Comparison between intravitreal injection of ranibizumab and combination of ranibizumab and triamcinolone acetate for the treatment of macular edema secondary to CRVO

  To compare the clinical effectiveness of 0.5 mg ranibizumab and combination of ranibizumab and triamcinolone 0.3/0.5mg for the treatment of macular oedema secondary to CRVO.Study assessments will be performed at screening, baseline and at monthly visits: Best-Corrected Visual Acuity: will be assessed at every study visit by using alandolt ringes VA testing chart at an initial testing distance of 6 m.

  2 year

• Comparison between intravitreal injection of ranibizumab and combination of ranibizumab and triamcinolone acetate for the treatment of macular edema secondary to CRVO

  To compare the clinical effectiveness of 0.5 mg ranibizumab and combination of ranibizumab and triamcinolone 0.3/0.5mg for the treatment of macular oedema secondary to CRVO.Study assessments will be performed at screening, baseline and at monthly visits: Optical Coherence Tomography: will be performed at every visit and the same machine will be used for assessment of the same patient throughout the study. investigator will evaluate the images according to central foveal thickness, and the retinal thickness at the foveal center point and to capture the presence or absence of qualitative parameters (i.e., intraretinal cystoid fluid and subretinal fluid).

  2 year

Study Arms (2)

Ranibizumab

ACTIVE COMPARATOR

intravetreal injection of Ranibizumab alone for treatment of patients with macular oedema after CRVO once per month and follow up

Drug: Ranibizumab

Ranibizumab and triamcinolone acetate

ACTIVE COMPARATOR

intravetreal injection of Ranibizumab and triamcinolone acetate for treatment of patients with macular oedema after CRVO once per month and follow up

Drug: Ranibizumab; Drug: triamcinolone acetate

Interventions

Ranibizumab DRUG

Intravitreal

Ranibizumab

triamcinolone acetate DRUG

intravitreal

Ranibizumab and triamcinolone acetate

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18 years of age or older with visual impairment resulting from macular edema secondary to CRVO.
• A BCVA approximate Snellen equivalents, 20/40.

You may not qualify if:

• Use of intra-vitreal anti-VEGF injections 3 months or less before baseline.
• Pan-retinal laser photocoagulation 3 months or less before baseline,
• Topical ocular or systemic corticosteroids administered for 30 consecutive days.
• Intraocular or periocular corticosteroid use 3 months or less before screening (study eye),
• Use of intraocular corticosteroid implants,
• Uncontrolled glaucoma (intraocular pressure \[IOP\] 30 mmHg with medication) at the time of screening or baseline,
• iris neovascularization or neo-vascular glaucoma.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Wael

Asyut, 11711, Egypt

RECRUITING

MeSH Terms

Conditions

Eye Diseases

Interventions

Ranibizumab; Triamcinolone

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Central Study Contacts

Wael Ismael

CONTACT

01006322380; wael.ali.ismael@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 1, 2019
• First Posted: July 7, 2020
• Study Start: May 16, 2019
• Primary Completion: August 1, 2021
• Study Completion: December 1, 2021
• Last Updated: July 7, 2020

Record last verified: 2019-11

Locations

EG (1)