Trial Outcomes & Findings for Pegaptanib Therapy in Non-Infectious Uveitic Cystoid Macular Edema (NCT NCT00790803)

Results Overview

The primary outcome was an improvement in VA greater than or equal to fifteen letters on the EDTRS chart.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

5 participants

Primary outcome timeframe

32 weeks

Results posted on

2022-03-15

Participant Flow

Five patients with non-infectious uveitis, ongoing for greater than three months but less than twelve months with associated CME. Patients were identified in the PI's regular medical clinic and received five intravitreal pegaptanib doses over the course of thirty weeks.

Five consecutive adult patients with non-infectious uveitis associated CME were chosen for this study. Only patients with a baseline best corrected VA between 20/40 and 20/200, attributable to CME, were selected for the study. In qualified patients with bilateral disease, the eye with the worse visual acuity was selected for the study eye.

Participant milestones

Participant milestones
Measure	Macugen Single arm pilot trial Pegaptanib (Macugen) : Five patients will receive intravitreous injections of Macugen 0.3 mg every 6 weeks as needed for a total of no more than five.
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pegaptanib Therapy in Non-Infectious Uveitic Cystoid Macular Edema

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Macugen n=5 Participants Single arm pilot trial Pegaptanib (Macugen) : Five patients will receive intravitreous injections of Macugen 0.3 mg every 6 weeks as needed for a total of no more than five.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	50.8 years STANDARD_DEVIATION 19.05781 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants

PRIMARY outcome

Timeframe: 32 weeks

Population: Five consecutive adult patients with non-infectious uveitis associated CME were chosen from the PI's regular medical clinic. Patients demonstrated, on fluorescein angiogram and/or optical tomography, bilateral or unilateral CME with non-infectious uveitis for greater than three months, but less than twelve.

The primary outcome was an improvement in VA greater than or equal to fifteen letters on the EDTRS chart.

Outcome measures

Outcome measures
Measure	Macugen n=5 Participants Single arm pilot trial Pegaptanib (Macugen) : Five patients will receive intravitreous injections of Macugen 0.3 mg every 6 weeks as needed for a total of no more than five.
Improvement in VA ETDRS >/= 15 Letters	1 participants

SECONDARY outcome

Timeframe: 32 weeks

Patients best corrected visual acuity was measured at each visit to monitor gain or loss of letters on the EDTRS chart.

Outcome measures

Outcome measures
Measure	Macugen n=5 Participants Single arm pilot trial Pegaptanib (Macugen) : Five patients will receive intravitreous injections of Macugen 0.3 mg every 6 weeks as needed for a total of no more than five.
Proportion of Patients Experiencing > 0 Letter Vision Gain and a < 15 Loss	5 paticipants

SECONDARY outcome

Timeframe: 32 weeks

Patients retinal thickness was measured at each visit bu imaging to monitor increase or decrease in thickness.

Outcome measures

Outcome measures
Measure	Macugen n=5 Participants Single arm pilot trial Pegaptanib (Macugen) : Five patients will receive intravitreous injections of Macugen 0.3 mg every 6 weeks as needed for a total of no more than five.
Decrease in CME as Evidenced by Imaging (Fluorescein Angiography and 50 Micron Change in OCT)	2 participants

SECONDARY outcome

Timeframe: 32 weeks

The degree of cell and flare was recorded at each visit during the course of the trial in the injected eye. In uveitis, severely inflamed vessels leak protein which clouds the normally clear aqueous. This looks hazy with the slit lamp. If severe, it disperses the light beam, causing flare. White or red blood cells may be observed: the presence of inflammatory cells in the anterior chamber suggests inflammation of the iris and ciliary body. Blood cells: grading of blood cells in the anterior chamber is as follows: * 0 - None. * 1+ - faint (barely detectable). * 2+ - moderate (clear iris and lens details). * 3+ - moderate (hazy iris and lens details). * 4+ - intense (fibrin deposits, coagulated aqueous).

Outcome measures

Outcome measures
Measure	Macugen n=5 Participants Single arm pilot trial Pegaptanib (Macugen) : Five patients will receive intravitreous injections of Macugen 0.3 mg every 6 weeks as needed for a total of no more than five.
A Decrease in Anterior Chamber Cells or Vitreous Cells or Haze in Injected Eye	0 participants

SECONDARY outcome

Timeframe: 32 weeks

No changes were to be made in immunodulatory medications of the patients unless needed for safety after in initiation of Macugen therapy.

Outcome measures

Outcome measures
Measure	Macugen n=5 Participants Single arm pilot trial Pegaptanib (Macugen) : Five patients will receive intravitreous injections of Macugen 0.3 mg every 6 weeks as needed for a total of no more than five.
Change in Immunomodulatory Medications (Topical, Periocular or Systemic) After the Initiation of Macugen Therapy	0 participants

Adverse Events

Macugen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Shree Kurup

Wake Forest Baptist Health Eye Center

Phone: 336-716-4091

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place