Trial Outcomes & Findings for Ranibizumab and Reduced Fluence PDT for AMD (NCT NCT00527475)

NCT ID: NCT00527475

Last Updated: 2025-11-28

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 60 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2025-11-28

Participant Flow

Participant milestones

Measure	Ranibizumab Group I will receive 0.5 mg. ranibizumab intraocularly initially. This will be repeated monthly for 3 months total and then as needed over the period of one year.	Reduced Fluence PDT & Ranibizumab Group II will receive Reduced Fluence-PDT (25 Joules) followed by 0.5 mg. of ranibizumab intraocularly on the same day. The second group will receive the combination of ranibizumab and RF-PDT as needed over a period of one year.
Overall Study STARTED	30	30
Overall Study COMPLETED	27	29
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ranibizumab and Reduced Fluence PDT for AMD

Baseline characteristics by cohort

Measure	Group I n=30 Participants Group I will receive 0.5 mg. ranibizumab intraocularly initially. This will be repeated monthly for 3 months total and then as needed over the period of one year.	Group II n=30 Participants Group II will receive Reduced Fluence-PDT (25 Joules) followed by 0.5 mg. of ranibizumab intraocularly on the same day. The second group will receive the combination of ranibizumab and RF-PDT as needed over a period of one year.	Total n=60 Participants Total of all reporting groups
Age, Continuous	79.1 years STANDARD_DEVIATION 8.35 • n=30 Participants	79.3 years STANDARD_DEVIATION 7.23 • n=30 Participants	79.2 years STANDARD_DEVIATION 7.72 • n=60 Participants
Sex: Female, Male Female	14 Participants n=30 Participants	18 Participants n=30 Participants	32 Participants n=60 Participants
Sex: Female, Male Male	16 Participants n=30 Participants	12 Participants n=30 Participants	28 Participants n=60 Participants
Region of Enrollment United States	30 participants n=30 Participants	30 participants n=30 Participants	60 participants n=60 Participants

PRIMARY outcome

Timeframe: 1 year

Population: Fifty-six participants completed the full 12 month study. Four subjects did not return for the 12 month visit. No patients terminated the study due to adverse events.

Outcome measures

Measure	Group I n=27 Participants Group I will receive 0.5 mg. ranibizumab intraocularly initially. This will be repeated monthly for 3 months total and then as needed over the period of one year.	Group II n=29 Participants Group II will receive Reduced Fluence-PDT (25 Joules) followed by 0.5 mg. of ranibizumab intraocularly on the same day. The second group will receive the combination of ranibizumab and RF-PDT as needed over a period of one year.
The Percentage of Patients With Less Than 15 Letters of ETDRS Visual Loss at 12 Months.	22 percentage of participants	14 percentage of participants

SECONDARY outcome

Timeframe: 1 year

Number of days to retreatment outcome changed to frequency of retreatments at maintenance visits.

Outcome measures

Measure	Group I n=27 Participants Group I will receive 0.5 mg. ranibizumab intraocularly initially. This will be repeated monthly for 3 months total and then as needed over the period of one year.	Group II n=29 Participants Group II will receive Reduced Fluence-PDT (25 Joules) followed by 0.5 mg. of ranibizumab intraocularly on the same day. The second group will receive the combination of ranibizumab and RF-PDT as needed over a period of one year.
Percentage of Participants With Retreatments Over One Year	33 % of subjects requiring additional injec	21 % of subjects requiring additional injec

SECONDARY outcome

Timeframe: 1 year

Additional number of ranibizumab injections given in each group over the 12 months

Outcome measures

Measure	Group I n=27 Participants Group I will receive 0.5 mg. ranibizumab intraocularly initially. This will be repeated monthly for 3 months total and then as needed over the period of one year.	Group II n=29 Participants Group II will receive Reduced Fluence-PDT (25 Joules) followed by 0.5 mg. of ranibizumab intraocularly on the same day. The second group will receive the combination of ranibizumab and RF-PDT as needed over a period of one year.
Number of Injections Over 12 Months	6.8 injections Standard Deviation 2.49	3.0 injections Standard Deviation 2.43

SECONDARY outcome

Timeframe: 1 year

Outcome measures

Measure	Group I n=27 Participants Group I will receive 0.5 mg. ranibizumab intraocularly initially. This will be repeated monthly for 3 months total and then as needed over the period of one year.	Group II n=29 Participants Group II will receive Reduced Fluence-PDT (25 Joules) followed by 0.5 mg. of ranibizumab intraocularly on the same day. The second group will receive the combination of ranibizumab and RF-PDT as needed over a period of one year.
Percentage of Subjects Gaining More Than 15 ETDRS Letters of Acuity	33 percentage	31 percentage

SECONDARY outcome

Timeframe: 1 year

Improvement in OCT (Optical coherent tomography) foveal thickness at 12 months/Number of microns in foveal thickness measurement

Outcome measures

Measure	Group I n=27 Participants Group I will receive 0.5 mg. ranibizumab intraocularly initially. This will be repeated monthly for 3 months total and then as needed over the period of one year.	Group II n=29 Participants Group II will receive Reduced Fluence-PDT (25 Joules) followed by 0.5 mg. of ranibizumab intraocularly on the same day. The second group will receive the combination of ranibizumab and RF-PDT as needed over a period of one year.
Improvement in OCT (Optical Coherent Tomography) Foveal Thickness at 12 Months	91.4 microns Standard Deviation 12.8	104.1 microns Standard Deviation 9.0

Adverse Events

Group I

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group II

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

David Callanan, MD

Texas Retina Associates

Phone: 817-261-9625

Email: dcallanan@texasretina.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place