Evaluation of the Efficacy of 2% Cyclosporine in Preventing Graft Rejection

NCT02206789 | Unknown

• 1 other identifier: IRB2011011CLI
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Aim/ Objective: Study consists of 2 separate and distinct entities A. Evaluation of the efficacy of 2% cyclosporine in preventing graft rejection in primary grafts w/o high risk characteristics study 1 (PKP study) B. Evaluation of the efficacy of 2% cyclosporine in preventing graft rejection in therapeutic keratoplasty- study 2(TKP study) Materials \& Methods: In both arms Patients requiring keratoplasty, above the age of 18 whom satisfactorily meet The inclusion criteria are different for each study Eligible candidates will be enrolled after signing an Informed Consent form Patients will be randomized into one of 2 groups

• Only on topical steroids group A
• On topical steroids + 2% cyclosporine Group B Study design: Prospective, randomized non-blinded study at a single centre. Methodology In both arms 1\. Schedule of topical steroid administration : 6 times for 2 weeks; 5 times for 2 weeks; 4 times for a month; 3 times for a month, and, subsequently twice-a-day until 1 year is completed Systemic steroids may be administered in the initial 2 weeks at the discretion of the investigators. (For all patients with fungal keratitis topical steroids can preferrably be administered only after 2 weeks post keratoplasty.) Until then voveran ophtha may be used 3\. Patients randomized to receive 2% cyclosporine will receive the same 3 times a day for 2years 4\. All patients will be followed for a minimum period of 2 years 5\. Follow up schedule - at 1 week, 2 weeks, 1 month, 2 months, 3 months, then every 3 months until 2 years are completed 6\. All episodes of graft rejection will be treated as per accepted norms and the patient will no longer follow the standardized protocol for steroid administration

Conditions

Corneal Graft Rejection

Outcome Measures

Primary Outcomes (1)

• graft rejection

  5 years

Secondary Outcomes (2)

• recovery from graft rejection

  5 years

• Incidence of graft rejection in patients maintained only on cyclosporine after 1year

  5 years

Other Outcomes (1)

• incidence of glaucoma and cataract.

  5 years

Study Arms (2)

penetrating keratoplasty

ACTIVE COMPARATOR

each arm will have two groups A and B.. Only on topical steroids(prednisolone acetate1%) group A On topical steroids + 2% cyclosporine Group B . Methodology of drug administration In both agroups 1. Schedule of topical steroid administration : 6 times for 2 weeks; 5 times for 2 weeks; 4 times for a month; 3 times for a month, and, subsequently twice-a-day until 1 year is completed . Topical steroids will be withdrawn at the end of ine year.Systemic steroids may be administered in the initial 2 weeks at the discretion of the investigators. 3\. Patients randomized to receive 2% cyclosporine will receive the same 3 times a day for 2years .

Drug: Prednisolone acetate1%,; Drug: Prednisolone acetate1%, cyclosporine 2%

therapeutic keratoplasty

ACTIVE COMPARATOR

each arm will have two groups A and B.. Only on topical steroids(prednisolone acetate1%) group A On topical steroids + 2% cyclosporine Group B . Methodology of drug administration In both agroups 1. Schedule of topical steroid administration : 6 times for 2 weeks; 5 times for 2 weeks; 4 times for a month; 3 times for a month, and, subsequently twice-a-day until 1 year is completed . Topical steroids will be withdrawn at the end of ine year.Systemic steroids may be administered in the initial 2 weeks at the discretion of the investigators. (For all patients with fungal keratitis topical steroids will be administered only after 2 weeks post keratoplasty.) Until then diclofenac sodium0.1% may be used 3. Patients randomized to receive 2% cyclosporine will receive the same 3 times a day for 2years .

Drug: Prednisolone acetate1%,; Drug: Prednisolone acetate1%, cyclosporine 2%

Interventions

Prednisolone acetate1%, DRUG

efficacy of prednisolone acetate1%alone versus prednisolone acetate 1%and cyclosporine 2% in preventing graft rejection

Also known as: pred forte (Prednisolone acetate1% )

penetrating keratoplasty; therapeutic keratoplasty

Prednisolone acetate1%, cyclosporine 2% DRUG

penetrating keratoplasty--efficacy of prednisolone acetate1%alone versus prednisolone acetate 1%and cyclosporine 2% in preventing graft rejection

Also known as: pred forte (Prednisolone acetate1% ), aurosporine (cyclosporine 2%)

penetrating keratoplasty; therapeutic keratoplasty

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• FOR ARM 1
• Age greater than 18 years
• Vision more than 6/60 in the fellow eye.
• No prior keratoplasty
• Not more than 1 quadrant of corneal vascularisation
• No peripheral anterior synechiae.
• No active ocular surface disease (VKC, dry eye,)
• Uncontrolled uveitis or glaucoma
• No limbal stem cell failure.
• No Prior h/o HSV
• Primarily patients with dystrophies, degenerations and pseudophakic bullous keratopathy and non vascularised non herpetic corneal scars will be enrolled
• ARM 2:
• Those patients with medically unresponsive keratitis with no limbal involvement and in whom the graft size can be restricted to less than 9mm will be included in the study. This is to ensure that postoperative issues such as synechiae, recurrence of infection and uncontrolled glaucoma do not affect the study. Grafts must also be clear at the end of one month after surgery for patients to continue in the study..
• Expected Outcome
• Incidence of graft rejection in both arms.

Sponsors & Collaborators

• Aravind Eye Care System: lead

Study Sites (1)

Dr.Anita Raghavan

Coimbatore, Tamil Nadu, 641014, India

RECRUITING

MeSH Terms

Interventions

prednisolone acetate

Study Officials

• Dr.Anita Raghavan

  Medical Cornea Consultant

  PRINCIPAL INVESTIGATOR

Central Study Contacts

dr.anita raghavan

CONTACT

04224360400; annieram2001@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2014
• First Posted: August 1, 2014
• Study Start: February 1, 2012
• Primary Completion: February 1, 2017
• Study Completion: December 1, 2017
• Last Updated: August 1, 2014

Record last verified: 2011-10

Locations

IN (1)